510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD March 2020
DEVICE: System 83 Plus Washer/Disinfector
Custom Ultrasonics, Inc. 510(k) NO: K173590(Traditional)
ATTN: Mario P. Infanti PHONE NO : 215 3641477 242
144 Railroad Drive SE DECISION MADE: 30-MAR-20
Ivyland PA 18974 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci X and Xi Surgical System
Intuitive Surgical, Inc 510(k) NO: K183086(Traditional)
ATTN: Brandon Hansen PHONE NO : 408 5232100
1266 Kifer Road SE DECISION MADE: 31-MAR-20
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOVIT AT-102 G2
Schiller AG 510(k) NO: K183425(Traditional)
ATTN: Sabina Standiford PHONE NO : 41 41 7664242
Altgasse 68 SE DECISION MADE: 02-MAR-20
Baar Zug CH 6341 510(k) STATEMENT
DEVICE: LiquiBand Plus
Advanced Medical Solutions Limited510(k) NO: K183570(Traditional)
ATTN: Martin Mitchell PHONE NO : 0044 1752 309360
Western Wood Way , Langage ScienceSE DECISION MADE: 09-MAR-20
Plymouth GB PL7 5BG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diapaste
Diadent Group International 510(k) NO: K190091(Traditional)
ATTN: Myung Sub Kim PHONE NO : 82 43 2662315
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 27-MAR-20
Cheongu-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AC5 Topical Gel
Arch Therapeutics, Inc. 510(k) NO: K190129(Traditional)
ATTN: Terrence Norchi PHONE NO : 617 4312316
235 Walnut Street, suite 6 SE DECISION MADE: 11-MAR-20
Framingham MA 01702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transferrin
BioSystems S.A. 510(k) NO: K190495(Traditional)
ATTN: Noelia Gil PHONE NO : 34 933 110000 4108
Costa Brava, 30 SE DECISION MADE: 16-MAR-20
Barcelona ES 08030 510(k) STATEMENT
DEVICE: Lubrina 2
J. Mortia USA, Inc. 510(k) NO: K190509(Traditional)
ATTN: Fujio Zushi PHONE NO : 949 5819600
9 Mason SE DECISION MADE: 04-MAR-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters
C.R. Bard 510(k) NO: K190527(Traditional)
ATTN: Jonathan Holmes PHONE NO : 480 3506161
605 N 5600 W SE DECISION MADE: 05-MAR-20
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant
Ossio Ltd. 510(k) NO: K190652(Traditional)
ATTN: Taly Lindner PHONE NO : 972 4 9986600
8 HaTochen St. SE DECISION MADE: 06-MAR-20
Caesarea IL 3079861 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AnatomicAligner
The Methodist Hospital Research In510(k) NO: K190767(Traditional)
ATTN: Christina Talley PHONE NO : 713 3639155
Methodist Research Institute 6670 SE DECISION MADE: 16-MAR-20
Houston TX 77030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Health Expert Electronic Stimulator (model: AST-3000L)
Shenzhen OSTO Technology Company L510(k) NO: K190783(Traditional)
ATTN: Li Yang PHONE NO : 86 755 29769546
No.43 Longfeng Road, Xinsheng CommSE DECISION MADE: 14-MAR-20
Longgang District,Shenzhen City C510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SwabTip Male Disinfectant Cap
ICU Medical 510(k) NO: K190918(Traditional)
ATTN: Nichelle Cato PHONE NO : 224 7062852
600 N. Field Drive SE DECISION MADE: 06-MAR-20
Lake Forest IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RefleXion Medical Radiotherapy System
RefleXion Medical, Inc. 510(k) NO: K190978(Traditional)
ATTN: Kathy O’Shaughnessy PHONE NO : 650 2399070 1035
25841 Industrial Blvd, Suite 275 SE DECISION MADE: 12-MAR-20
Hayward CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kinepict Medical Imaging Tool version v2.2
Kinepict Health Ltd 510(k) NO: K190993(Traditional)
ATTN: Lilla Strobel PHONE NO : 36 31 7852260
Kelta k z SE DECISION MADE: 05-MAR-20
Budakeszi HU 2092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
Maquet Critical Care AB 510(k) NO: K191027(Traditional)
ATTN: Kribu Valdre PHONE NO : 46 10 3357300
Rontgenvagen 2 SE DECISION MADE: 18-MAR-20
Solna SE 17154 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NightOwl
Ectosense nv 510(k) NO: K191031(Traditional)
ATTN: Bart Van Pee PHONE NO : 32 2 5889044
Bosbessenlaan 19A SE DECISION MADE: 06-MAR-20
Rotselaar BE 3110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Park's Pectus System
TDM Co. Ltd. 510(k) NO: K191057(Traditional)
ATTN: Jung-Wook Choi PHONE NO : 82 62 9717460
69, Cheomdan Venture so-ro, 37 beoSE DECISION MADE: 19-MAR-20
Gwangju KR 61003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
SSI Diagnostica A/S 510(k) NO: K191184(Traditional)
ATTN: Pernille Landsbo Elverdal PHONE NO : 45 48299100
2 Herredsvejen SE DECISION MADE: 05-MAR-20
Hilleroed DK 3400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PregSense
Nuvo-Group Ltd. 510(k) NO: K191401(Traditional)
ATTN: Adar Shani PHONE NO : 972 54 2347770
Yigal Alon 94. St, Alon Tower 1 SE DECISION MADE: 27-MAR-20
Tel Aviv IL 6789155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KinematX Total Wrist Arthroplasty System
Extremity Medical, LLC. 510(k) NO: K191525(Traditional)
ATTN: Brian Smekal PHONE NO : 973 5888980
300 Interpace Parkway, Suite 410 SE DECISION MADE: 04-MAR-20
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Broncholab
Fluidda Inc. 510(k) NO: K191550(Traditional)
ATTN: Anjali Nair PHONE NO : 1 857 2729613
750 N. San Vicente Blvd, Suite 800SE DECISION MADE: 04-MAR-20
West Hollywood CA 90069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Konan Specular Microscope XVII
Konan Medical, Inc. 510(k) NO: K191558(Traditional)
ATTN: Tatsuya Kasahara PHONE NO : 81 798 363456
10-29, Miyanishicho SE DECISION MADE: 26-MAR-20
Nishinomiya JP 662-0976 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
HORIBA ABX SAS 510(k) NO: K191562(Traditional)
ATTN: Caroline Ferrer PHONE NO : 0033 4670 141516
Parc Euromedecine, Rue Du Caducee SE DECISION MADE: 06-MAR-20
Montpellier Cedex 4 FR 341184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avinent Surgical Tray
AVINENT Implant System, S.L.U. 510(k) NO: K191566(Traditional)
ATTN: Anna Cortina PHONE NO : 0034 902 383848
Pol. Ind. Santa Anna SE DECISION MADE: 06-MAR-20
Santpedor ES 08251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: sam 2.0 Long Duration Ultrasound System
ZetrOZ Systems, LLC 510(k) NO: K191568(Traditional)
ATTN: Sabrina Lewis PHONE NO :
56 Quarry Road SE DECISION MADE: 06-MAR-20
Trumbull CT 06611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PhotonBlade with Smoke Evacuation
Invuity Inc. 510(k) NO: K191583(Traditional)
ATTN: Dione Fuller PHONE NO : 415 6552160
444 De Haro Street SE DECISION MADE: 06-MAR-20
San Francisco CA 94107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Encision AEM Monopolar Laparoscopic Instruments and Accessories
Encision Incorporated 510(k) NO: K191612(Traditional)
ATTN: Denise Baker PHONE NO : 303 4442600
6797 Winchester Circle SE DECISION MADE: 20-MAR-20
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version
Fisher & Paykel Healthcare Limited510(k) NO: K191624(Traditional)
ATTN: Nicholas Yap PHONE NO : 64 9 5740123
15 Maurice Paykel Place SE DECISION MADE: 09-MAR-20
Auckland NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
MedTest Dx 510(k) NO: K191638(Traditional)
ATTN: William Cripps PHONE NO : 734 4878300 120
5449 Research Drive SE DECISION MADE: 12-MAR-20
Canton MI 48188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEGAFIX® Pedicle Screw Spinal System
SeohanCare Co., Ltd 510(k) NO: K191655(Traditional)
ATTN: Chae Lynn Song PHONE NO : 82 70 87696041
2F Da-dong 22, Gimpo-daero 2918beoSE DECISION MADE: 06-MAR-20
Gimpo-si KR 10020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bioland Blood Glucose Monitoring System
Bioland Technology Ltd. 510(k) NO: K191657(Traditional)
ATTN: Ke-Min Jen PHONE NO : 86 755 28961218
No. A6B7 (Block G), ShangRong InduSE DECISION MADE: 20-MAR-20
Baolong Community, Longgang Distri510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IV Sets not made with PVC
B. Braun Medical Inc. 510(k) NO: K191658(Traditional)
ATTN: Angela J. Caravella PHONE NO : 610 5962966
901 Marcon Boulevard SE DECISION MADE: 19-MAR-20
Allentown PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AZUR Vascular Plug
MicroVention Inc. 510(k) NO: K191680(Traditional)
ATTN: Ganesh Balachander PHONE NO : 714 2478000
35 Enterprise SE DECISION MADE: 20-MAR-20
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OptikView GUP2103CMI
The Linden Group Corp 510(k) NO: K191705(Traditional)
ATTN: James Chen PHONE NO : 973 9838809
2B Wing Drive SE DECISION MADE: 16-MAR-20
Cedar Knolls NJ 07927 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-STRUT Vertebral Implant
Hyprevention SAS 510(k) NO: K191709(Traditional)
ATTN: Cecile Vienney PHONE NO : 330 557 102852
PTIB - Hopital Xavier Arnozan - AvSE DECISION MADE: 05-MAR-20
PESSAC Cedex FR 33604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Somryst
Pear Therapeutics, Inc. 510(k) NO: K191716(Traditional)
ATTN: David Amor PHONE NO : 786 5461806
201 Mission St. #1450 SE DECISION MADE: 23-MAR-20
San Francisco CA 94105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPT Hip System
Zimmer Inc 510(k) NO: K191735(Traditional)
ATTN: Caleb Barylski PHONE NO : 574 3710250
1800 W Center Street SE DECISION MADE: 20-MAR-20
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIGR Matrix Surgical Mesh, TIGR Surgical Mesh
Novus Scientific AB 510(k) NO: K191749(Traditional)
ATTN: Thomas Engstrom PHONE NO : 46 18 7001150
Virdings Alle 2 SE DECISION MADE: 26-MAR-20
Uppsala SE se-754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs)
Medline Industries, Inc. 510(k) NO: K191753(Traditional)
ATTN: Claire Pigman PHONE NO : 847 6434071
Three Lakes Drive SE DECISION MADE: 17-MAR-20
Northfield IL 60093 510(k) STATEMENT
DEVICE: MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC
CooperVision, Inc. 510(k) NO: K191763(Traditional)
ATTN: Marie Dutton PHONE NO : 925 2516645
5870 Stoneridge Drive, Suite 1 SE DECISION MADE: 23-MAR-20
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
Medtronic Sofamor Danek, USA Inc. 510(k) NO: K191788(Traditional)
ATTN: Mia Wiggins PHONE NO : 901 3992699
1800 Pyramid Place SE DECISION MADE: 23-MAR-20
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
Fisher & Paykel Healthcare Ltd 510(k) NO: K191818(Traditional)
ATTN: Reena Daken PHONE NO : 64 9 5740100
15 Maurice Paykel Place, East TamaSE DECISION MADE: 19-MAR-20
Auckland NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sunmed Disposable Angio-Closure Pads
Sunny Medical Device (Shenzhen) Co510(k) NO: K191827(Traditional)
ATTN: James Qi Zhang PHONE NO : 949 2168838
56 Lehigh Aisle SE DECISION MADE: 16-MAR-20
Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: gammaCore Sapphire
Electrocore, Inc. 510(k) NO: K191830(Traditional)
ATTN: Mike Romaniw PHONE NO :
150 Allen Road, Suite 201 SE DECISION MADE: 26-MAR-20
Basking Ridge NJ 07920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clearform Aligners
Motor City Lab Works 510(k) NO: K191838(Traditional)
ATTN: Christina Groth PHONE NO : 248 2509519
2200 Holland Street SE DECISION MADE: 20-MAR-20
Birmingham MI 48009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Compression Therapy Device
Guangzhou Longest Science & Techno510(k) NO: K191856(Traditional)
ATTN: Xiaobing Luo PHONE NO : 86 020 66353999
5&6f, Building B4, No.11, Kaiyuan SE DECISION MADE: 19-MAR-20
Guangzhou CN 510530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential
Semperit Technische Produkte Gesel510(k) NO: K191860(Abbreviated)
ATTN: Andreas Woess PHONE NO : 43 2630 3100
Triester Bundesstrasse 26 SE DECISION MADE: 31-MAR-20
Wimpassing AT 2632 510(k) STATEMENT
DEVICE: iCEWav Neuromonitoring Platform
iCE Neurosystems, Inc. 510(k) NO: K191868(Traditional)
ATTN: Allen Waziri PHONE NO : 646 2509166
1875 Connecticut Ave NW, Suite 121SE DECISION MADE: 31-MAR-20
Washington DC 20007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim
Molnlycke Health Care, US LLC 510(k) NO: K191869(Traditional)
ATTN: Leonard Stewart PHONE NO : 470 3750178
5550 Peachtree Parkway, Suite 500 SE DECISION MADE: 13-MAR-20
Norcross GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution
Menicon Co., Ltd. 510(k) NO: K191872(Traditional)
ATTN: Tetsuji Kawai PHONE NO : 81 52 9351676
21-19, Aoi 3, Naka-ku SE DECISION MADE: 02-MAR-20
Nagoya JP 460-0006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PulmoScan
Cognita Labs, LLC 510(k) NO: K191876(Traditional)
ATTN: Rajoshi Biswas PHONE NO : 832 5383042
700 N Main St. Ste C1 SE DECISION MADE: 18-MAR-20
Santa Ana CA 92701 510(k) STATEMENT
DEVICE: Single Use Grasping Forceps
Zhejiang Chuangxiang Medical Techn510(k) NO: K191900(Traditional)
ATTN: Lucius Long PHONE NO : 86 0571 89167088 8099
301B, No.22, XinYan Road SE DECISION MADE: 27-MAR-20
Hanzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HepaShield Bacterial Viral Breathing System Filter
Flexicare Medical Limited 510(k) NO: K191909(Traditional)
ATTN: Joel Biddle PHONE NO : 44 1443 474560
Cynon Valley Business Park SE DECISION MADE: 23-MAR-20
Mountain Ash GB cf45 4er 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpaceStation MRI
B. Braun Melsugen AG 510(k) NO: K191910(Traditional)
ATTN: Ullrich Trottier PHONE NO : 49 5661 711461
Carl-Braun-Strasse 1 SE DECISION MADE: 12-MAR-20
Melsungen DE 34212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BiWaze Cough
ABMRC LLC 510(k) NO: K191912(Traditional)
ATTN: Chad M Boerst PHONE NO : 1 843 8302223
239, Fair Child Street, Daniel IslSE DECISION MADE: 27-MAR-20
Charleston SC 29492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V
Medicine Industries, Inc 510(k) NO: K191915(Traditional)
ATTN: Jenneifer Mason PHONE NO : 847 6433652
Three Lake Drive SE DECISION MADE: 06-MAR-20
Northfiled IL 60093 510(k) STATEMENT
DEVICE: Ezfil
Meta Biomed Co., Ltd. 510(k) NO: K191991(Traditional)
ATTN: Suk Song Oh PHONE NO : 82 43 2308841
270, Osong Saengmyeong 1-ro, OsongSE DECISION MADE: 05-MAR-20
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TheraBase, TheraBase Ca
Bisco, Inc. 510(k) NO: K192007(Traditional)
ATTN: Diana Vu PHONE NO : 847 5346000
1100 West Irving Park Rd. SE DECISION MADE: 17-MAR-20
Schaumburg IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LaserShot M, NaviLase
Vitrolife GmbH 510(k) NO: K192008(Abbreviated)
ATTN: Susanne Schweitzer PHONE NO : 49 087 659399019
Dr. -Pauling-Str.9 SE DECISION MADE: 25-MAR-20
Bruckberg DE 84079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fixone Biocomposite Small Anchor
AJU Pharm Co., Ltd. 510(k) NO: K192032(Traditional)
ATTN: Lee Gun Tak PHONE NO : 82 31 7654420
A-207, 697, Pangyo-ro SE DECISION MADE: 03-MAR-20
Seongnam-si KR 13511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Torc Body
Johari Digital Healthcare Limited 510(k) NO: K192039(Traditional)
ATTN: Pooja Johari PHONE NO : 91 98 29954228
G-582, 584 EPIP, Boranada SE DECISION MADE: 29-MAR-20
Jodhpur IN 342008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JJ Series Container System
Aesculap, Inc. 510(k) NO: K192056(Traditional)
ATTN: Sierra Mertz PHONE NO : 610 9849076
3773 Corporate Parkway SE DECISION MADE: 27-MAR-20
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
Ethicon, Inc. 510(k) NO: K192144(Traditional)
ATTN: Eleanor Zhou PHONE NO : 908 2183198
Route 22 West, P.O. Box 151 SE DECISION MADE: 25-MAR-20
Somerville NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
NeuroVention LLC 510(k) NO: K192162(Traditional)
ATTN: Rohit Khanna PHONE NO : 386 2526421
645 S. Beach St. SE DECISION MADE: 13-MAR-20
Daytona Beach FL 32114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR
Olympus Medical Systems Corp. 510(k) NO: K192164(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 06-MAR-20
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPIDPoint 500e Blood Gas System
Siemens Healthcare Diagnostics, In510(k) NO: K192240(Special)
ATTN: Lois Parillon PHONE NO : 781 2693917
2 Edgewater Drive SE DECISION MADE: 27-MAR-20
Norwood MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
O & M Haylard, Inc. 510(k) NO: K192241(Abbreviated)
ATTN: Steven Dowdley PHONE NO : 678 4518062
5405 Windward Parkway SE DECISION MADE: 13-MAR-20
Alpharetta GA 30004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wolf445nm
A.R.C. Laser GmbH 510(k) NO: K192272(Traditional)
ATTN: Angela Thyzel PHONE NO : 49 91121 7990
Bessemer St. 14 SE DECISION MADE: 17-MAR-20
Nurnberg DE 90411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DiaFil Flow
Diadent Group International 510(k) NO: K192284(Traditional)
ATTN: Kab Sun Lee PHONE NO : 82 43266 2315
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 25-MAR-20
Cheongji-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnlightenVue Microendoscopy System
EnlightenVue, Inc. 510(k) NO: K192300(Traditional)
ATTN: Giacomo Basadonna PHONE NO : 202 4275177
1111 Race Street, Suite 6a SE DECISION MADE: 20-MAR-20
Denver CO 80206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JR.MEDIK Latex Surgeon’s Gloves Powder Free
JR Engineering & Medical Technolog510(k) NO: K192328(Abbreviated)
ATTN: Ganesan Subramaniam PHONE NO : 603 60572081
Lot 8 &10, Jalan Zurah 3 & Lot 1 &SE DECISION MADE: 10-MAR-20
Hulu Selangor MY 44200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOLab Clear Aligners
New England Ortho Lab, Inc. 510(k) NO: K192338(Traditional)
ATTN: Olivia Channon PHONE NO : 800 9226365
3 Riverside Drive SE DECISION MADE: 12-MAR-20
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SonoVision Ultrasound Imaging System
Tissue Differentiation Intelligenc510(k) NO: K192388(Abbreviated)
ATTN: Christian Zaal PHONE NO : 305 3512011
234 NE 4th Avenue SE DECISION MADE: 12-MAR-20
Delray Beach FL 33483 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
Medtronic, Inc. 510(k) NO: K192389(Traditional)
ATTN: Nancy Cameron PHONE NO : 763 5262355
8200 Coral Sea Street NE SE DECISION MADE: 27-MAR-20
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SiteSeal Femoral Compression Device
Ensite Vacular, LLC 510(k) NO: K192413(Traditional)
ATTN: Tom Reidy PHONE NO : 913 7775277
10900 South Clay Blair Blvd, SuiteSE DECISION MADE: 31-MAR-20
Olathe KS 66061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arterys MICA
Arterys Inc. 510(k) NO: K192437(Traditional)
ATTN: Sharon Cholowsky PHONE NO : 403 9239688
51 Federal Street Suite 305 SE DECISION MADE: 25-MAR-20
San Francisco CA 94107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MeDioStar
ASCLEPION LASER TECHNOLOGIES GMBH 510(k) NO: K192483(Special)
ATTN: Antje Katzer PHONE NO : 49 3641 7700309
Busseler Str. 10 SE DECISION MADE: 13-MAR-20
Jena DE 07747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fixone Biocomposite Anchor
AJU Pharm Co., Ltd. 510(k) NO: K192484(Special)
ATTN: Kim Jung Gil PHONE NO : 82 31 7654420
A-207, 697, Pangyo-ro SE DECISION MADE: 11-MAR-20
Seongnam-si KR 13511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tevdek II, "Silky" II Polydek, 'Cottony' II, NextStitch
Teleflex Medical 510(k) NO: K192490(Traditional)
ATTN: Robin Haden PHONE NO : 919 4338046
3015 Carrington Mill Blvd SE DECISION MADE: 30-MAR-20
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Galan 3T, MRT-3020, V6.0
Canon Medical Systems Corporation 510(k) NO: K192506(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 02-MAR-20
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAFIL & DIAFIL Capsule
Diadent Group International 510(k) NO: K192510(Traditional)
ATTN: Kab Sun Lee PHONE NO : 82 43 2662315
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 20-MAR-20
Cheongu-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CrossBay Endometrial Tissue Sampler (ETS)
CrossBay Medical 510(k) NO: K192534(Traditional)
ATTN: Piush Vidyarthi PHONE NO : 415 7282847
13240 Evening Creek Drive, Suite 3SE DECISION MADE: 25-MAR-20
San Diego CA 92128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation 510(k) NO: K192574(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 09-MAR-20
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CURA 778
FMI Medical Systems Inc. 510(k) NO: K192590(Traditional)
ATTN: Dazhuang Meng PHONE NO : 440 6005952
29001 Solon Road, Unit A SE DECISION MADE: 05-MAR-20
Solon OH 44139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: High Strength Suture
Yunyi (Beijing) Medical Device Co.510(k) NO: K192637(Traditional)
ATTN: Xiaowei Liu PHONE NO : 86 10 57234533
Floor 1-4, Building 4, No. 9 TianfSE DECISION MADE: 02-MAR-20
Beijing CN 102600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump
Guangzhou Yongyi Industrial Co., L510(k) NO: K192640(Traditional)
ATTN: Jian Zhongrong PHONE NO : 86 020 39953345
B3, No. 29, Qixin Road, Dongchong SE DECISION MADE: 30-MAR-20
Guangzhou CN 511400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Instinct Plus Endoscopic Clipping Device
Cook Endoscopy 510(k) NO: K192697(Traditional)
ATTN: Karthik Pillai PHONE NO : 812 3353575 104929
4900 Bethania Station Road SE DECISION MADE: 05-MAR-20
Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Altera Filter and HME/Filter
Meditera Tibbi Malzeme San. ve Tic510(k) NO: K192713(Traditional)
ATTN: Cenk Kilic Kalkan PHONE NO : 90 232 5135110 177
Ibni Melek OSB Mah. TOSBI Yol 4 SoSE DECISION MADE: 16-MAR-20
Izmir TR 35900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIA Stapler with Tri-Staple Technology
Covidien 510(k) NO: K192720(Traditional)
ATTN: Sarah Tang PHONE NO : 86 21 33230158
Rooms 501,502,601,602, No.3 buildiSE DECISION MADE: 13-MAR-20
Min Hang District CN 201114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Propeller Sensor for Symbicort
Reciprocal Labs Corporation 510(k) NO: K192724(Traditional)
ATTN: Greg Dunkelberger PHONE NO : 608 2510470
1 S. Pinckney St. Suite 610 SE DECISION MADE: 26-MAR-20
Madison WI 53703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BodyGuardian Remote Monitoring System
Preventice Technologies, Inc. 510(k) NO: K192732(Traditional)
ATTN: Charles Rector PHONE NO : 952 5641465
3052 Hwy52 N, Building 003-2 SE DECISION MADE: 26-MAR-20
Rochester MN 55901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuralScan System
Medeia, Inc. 510(k) NO: K192753(Traditional)
ATTN: Slav Danev PHONE NO : 800 4334609
7 W Figueroa Street, Suites 300 SE DECISION MADE: 17-MAR-20
Santa Barbara CA 93101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apollo Suture Anchor System
Valeris Medical 510(k) NO: K192810(Special)
ATTN: Brendan Thies PHONE NO : 888 4043980
200 Cobb Pkwy N, Building 200, SuiSE DECISION MADE: 11-MAR-20
Marietta GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Plasma IQ
Neauvia North America, Inc 510(k) NO: K192813(Traditional)
ATTN: Misty Williams PHONE NO : 984 7775292
8480 Honeycutt Rd SE DECISION MADE: 06-MAR-20
Raleigh NC 27615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys BRAHMS PCT
Roche Diagnostics 510(k) NO: K192815(Traditional)
ATTN: Wes Gerbig PHONE NO : 317 5214371
9115 Hague Road SE DECISION MADE: 09-MAR-20
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Curian HpSA, Curian Analyzer
Meridian Bioscience, Inc. 510(k) NO: K192817(Traditional)
ATTN: Cathlena Martinez PHONE NO : 513 2713700
3471 River Hills Drive SE DECISION MADE: 13-MAR-20
Cincinnati OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System
Stryker Corporation 510(k) NO: K192818(Traditional)
ATTN: Kristi Ashton PHONE NO : 269 3895929
4100 E. Milham Avenue SE DECISION MADE: 31-MAR-20
Kalamazoo MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRI ECG Patient Cable
Ivy Biomedical Systems, Inc. 510(k) NO: K192852(Traditional)
ATTN: Alejandra Aceves PHONE NO : 203 4814183
11 Business Park Drive SE DECISION MADE: 28-MAR-20
Branford CT 06405 510(k) STATEMENT
DEVICE: MammoScreen
Therapixel 510(k) NO: K192854(Traditional)
ATTN: Quentin de Snoeck PHONE NO : 0033 9 72552039
Village By CA - Le Theseus, Rue ClSE DECISION MADE: 25-MAR-20
Valbonne FR 06560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
Volcano Corporation 510(k) NO: K192886(Traditional)
ATTN: Jenny Fu PHONE NO : 858 7204094
3721 Valley Centre Drive, Ste 500 SE DECISION MADE: 26-MAR-20
San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EzOrtho
Ewoo Soft Co., Ltd. 510(k) NO: K192888(Traditional)
ATTN: Young Seok Kim PHONE NO : 82 31 80156172
801-ho, Vatechnetworks Bldg. 13, SSE DECISION MADE: 13-MAR-20
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: icotec Cervical Cage
icotec ag 510(k) NO: K192897(Traditional)
ATTN: Marina Hess PHONE NO : 41 71757 0024
Industriestrasse 12 SE DECISION MADE: 20-MAR-20
9450 Altstaetten(SG) CH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Creo Electrosurgical System with HS1 Hemostasis Accessory
Creo Medical Ltd. 510(k) NO: K192905(Traditional)
ATTN: Leif Geoghegan PHONE NO : 44 1291 606005
Creo House, Unit 2, Beaufort Park SE DECISION MADE: 19-MAR-20
Chepstow GB NP16 5UH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mecta-C Stand Alone
Medacta International SA 510(k) NO: K192906(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 04-MAR-20
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit
Siemens Medical Solutions USA Inc.510(k) NO: K192924(Traditional)
ATTN: Andrew Turner PHONE NO : 610 8505627
40 Liberty Boulevard, MailCode 65-SE DECISION MADE: 11-MAR-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 32HL512D
LG Electronics Inc. 510(k) NO: K192925(Traditional)
ATTN: Jinhwan Jun PHONE NO : 82 31 80665641
222, LG-ro, Cheongho-ri, Jinwi-myeSE DECISION MADE: 13-MAR-20
Pyeongtaek-si KR 17709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
Ellipse A/S 510(k) NO: K192951(Traditional)
ATTN: Ole Kofod PHONE NO : 45 23958055
Agern Alle 11 SE DECISION MADE: 26-MAR-20
Hoersholm DK dk-2970 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medacta Shoulder System
Medacta International, SA 510(k) NO: K192967(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 25-MAR-20
Castel San Pietro CH 6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS Martin Individual Patient Solutions (IPS) Planning System
KLS-Martin L.P. 510(k) NO: K192979(Traditional)
ATTN: Jennifer Damato PHONE NO : 800 6251557
11201 Saint Johns Industrial ParkwSE DECISION MADE: 11-MAR-20
Jacksonville FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aina HbA1c Monitoring System 2
Jana Care, Inc 510(k) NO: K192987(Traditional)
ATTN: Michal Depa PHONE NO : 617 2299160
8 Saint Mary's St, Suite 936 SE DECISION MADE: 26-MAR-20
Boston MA 02215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DANNIK Disposable Monopolar Laparoscopic Instrument
Dannik 510(k) NO: K193019(Traditional)
ATTN: Olga Haberlad PHONE NO : 407 9271743
941 W Morse Blvd. Suite 100 SE DECISION MADE: 04-MAR-20
Winter Park FL 32789 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HBP6 Settable, Resorbable Hemostatic Bone Paste
Orthocon, Inc. 510(k) NO: K193052(Traditional)
ATTN: Howard Schrayer PHONE NO : 609 2737350
1 Bridge Street, Suite 121 SE DECISION MADE: 27-MAR-20
Irvington NY 10533 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tina-quant Hemoglobin A1cDx Gen.3
Roche Diagnostics Operations (RDO)510(k) NO: K193053(Traditional)
ATTN: Leslie Patterson PHONE NO : 317 5217307
9115 Hague Rd SE DECISION MADE: 26-MAR-20
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sectra Digital Pathology Module
Sectra AB 510(k) NO: K193054(Traditional)
ATTN: Edoardo Mastrovito PHONE NO : 46 13 235206
Teknikringen 20 SE DECISION MADE: 31-MAR-20
Linkoping SE 58330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G1 40 Radiopaque Bone Cement
G21 S.r.l. 510(k) NO: K193059(Traditional)
ATTN: Filippo Foroni PHONE NO : 39 053530312
Via S. Pertini, 8 SE DECISION MADE: 19-MAR-20
San Possidonio IT 41039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G3 40 Radiopaque Bone Cement
G21 S.r.l 510(k) NO: K193061(Traditional)
ATTN: Flilippo Foroni PHONE NO : 39 05353 0312
Via S. Pertini, 8 SE DECISION MADE: 19-MAR-20
San Possidonio IT 41039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atlantis suprastructures
Dentsply Sirona Inc. 510(k) NO: K193064(Traditional)
ATTN: Karl Nittinger PHONE NO : 717 8494424
221 West Philadelphia Street, SuitSE DECISION MADE: 03-MAR-20
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lucent : IPL
LUVO Medical Technologies, Inc. 510(k) NO: K193072(Traditional)
ATTN: Gregory Berzak PHONE NO :
125 Fleming Dr SE DECISION MADE: 05-MAR-20
Cambridge CA N1T 2B8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIS CONNECT Conical Connection System
Dentsply Sirona 510(k) NO: K193078(Traditional)
ATTN: Karl Nittinger PHONE NO : 717 8494424
221 West Philadelphia Street, SuitSE DECISION MADE: 25-MAR-20
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rapid ICH
iSchemaView Incorporated 510(k) NO: K193087(Traditional)
ATTN: James Rosa PHONE NO : 303 7043374
433 Park Point Dr., Ste. 220 SE DECISION MADE: 31-MAR-20
Golden CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIX Impact
Siemens Medical Solutions USA, Inc510(k) NO: K193089(Traditional)
ATTN: Martin Rajchel PHONE NO : 610 4486545
40 Liberty Boulevard, Mailcode 65-SE DECISION MADE: 20-MAR-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System
OrthoPediatrics, Corp 510(k) NO: K193100(Traditional)
ATTN: Jackie Jaskula PHONE NO : 574 2670817
2850 Frontier Drive SE DECISION MADE: 24-MAR-20
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omnifix Low Dead Space Luer Lock Syringe
B. Braun Medical Inc. 510(k) NO: K193101(Traditional)
ATTN: Tracy Larish PHONE NO : 610 5962941
901 Marcon Blvd. SE DECISION MADE: 05-MAR-20
Allentown PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System
Conformis, Inc. 510(k) NO: K193105(Traditional)
ATTN: Nancy Giezen PHONE NO : 781 3459058
600 Technology Park Drive SE DECISION MADE: 13-MAR-20
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bonecam Suture Anchor
Valeris Medical Inc. 510(k) NO: K193108(Special)
ATTN: Brendan Thies PHONE NO : 888 4043980
200 Cobb Pkwy N, Building 200, SuiSE DECISION MADE: 26-MAR-20
Marietta GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
3M Health Care 510(k) NO: K193110(Traditional)
ATTN: Andrew Wingen PHONE NO : 651 7330929
2510 Conway Avenue, Bldg. 275-5W-0SE DECISION MADE: 13-MAR-20
St. Paul MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims
ECO Medi Glove SDN BHD 510(k) NO: K193121(Traditional)
ATTN: Suresh Kumar PHONE NO : 605 8912777
Lot 23826, Jalan Tembaga Kuning, KSE DECISION MADE: 20-MAR-20
Perak MY 34600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Customized Mandible Recon Plate Kit
Stryker 510(k) NO: K193136(Special)
ATTN: Zainab Amini PHONE NO : 269 3898349
750 Trade Centre Way - Suite 200 SE DECISION MADE: 26-MAR-20
Portage MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProVecta 3D Prime Ceph
Durr Dental SE 510(k) NO: K193139(Traditional)
ATTN: Oliver Lange PHONE NO : 49 07142 7050
Hopfigheimer Str. 17 SE DECISION MADE: 05-MAR-20
Bietigheim-Bissingen DE 74321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Facial iD Plating System
Stryker 510(k) NO: K193143(Special)
ATTN: Zainab Amini PHONE NO : 269 3898349
750 Trade Centre Way- Suite 200 SE DECISION MADE: 26-MAR-20
Portage MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-Line Hernia Mesh
Deep Blue Medical Advances, Inc. 510(k) NO: K193144(Traditional)
ATTN: William Perry PHONE NO : 408 2429323
701 W Main Street, Suite 410 SE DECISION MADE: 30-MAR-20
Durham NC 27701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch
Megadyne Medical Products, Inc. 510(k) NO: K193145(Traditional)
ATTN: Sharon Sussex PHONE NO : 787 2726500
11506 South State Street SE DECISION MADE: 24-MAR-20
Draper UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
Stereotaxis, Inc. 510(k) NO: K193147(Traditional)
ATTN: Kenneth H. Lock PHONE NO : 314 6786123
4320 Forest Park Avenue, Suite 100SE DECISION MADE: 05-MAR-20
St. Louis MO 63108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
ACIST Medical Systems, Inc. 510(k) NO: K193183(Special)
ATTN: Angela Johnson PHONE NO : 952 9939300
7905 Fuller Rd SE DECISION MADE: 20-MAR-20
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uMR Omega
Shanghai United Imaging Healthcare510(k) NO: K193200(Traditional)
ATTN: Xin Gao PHONE NO : 86 021 67076888 5386
NO. 2258 Chengbei Road, SE DECISION MADE: 27-MAR-20
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nano FortiFix® System
Nanovis Spine LLC 510(k) NO: K193211(Traditional)
ATTN: Matthew Hedrick PHONE NO : 877 9076266
5865 East State Rd. 14 SE DECISION MADE: 20-MAR-20
Columbia City IN 46725 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.CT Lung CAD
Siemens Medical Solutions, Inc 510(k) NO: K193216(Traditional)
ATTN: Abhineet Johri PHONE NO : 484 6808723
65 Valley Stream Parkway SE DECISION MADE: 09-MAR-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transpara
ScreenPoint Medical B.V. 510(k) NO: K193229(Traditional)
ATTN: Umar Waqas PHONE NO : 31 24303 0045
Mercator II, 7th floor, ToernooiveSE DECISION MADE: 05-MAR-20
Nijmegen NL 6525EC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Indigo Aspiration System – Lightning Aspiration Tubing
Penumbra, Inc. 510(k) NO: K193244(Traditional)
ATTN: Micaela Victoria PHONE NO : 510 9952082
One Penumbra Place SE DECISION MADE: 13-MAR-20
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anjon Bremer Halo System
Anjon Holdings LLC 510(k) NO: K193256(Traditional)
ATTN: Kenneth A Collins PHONE NO : 904 7309373
4801 Dawin Road SE DECISION MADE: 02-MAR-20
Jacksonville FL 32207 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DR 600 with Tomosynthesis
Agfa N.V. 510(k) NO: K193262(Traditional)
ATTN: Wim Govaerts PHONE NO : 32 3444 6246
Septestraat 27 SE DECISION MADE: 09-MAR-20
Mortsel BE B-2640 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Al-Rad Companion (Musculoskeletal)
Siemens Medical Solutions USA, Inc510(k) NO: K193267(Traditional)
ATTN: Alaine Medio PHONE NO : 865 2060337
810 Innovation Drive SE DECISION MADE: 16-MAR-20
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hepatic VCAR
GE Medical Systems SCS 510(k) NO: K193281(Traditional)
ATTN: Lifeng Wang PHONE NO : 86 10 57083145
283 rue de la Miniere SE DECISION MADE: 20-MAR-20
Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)
Abbott (St. Jude Medical) 510(k) NO: K193310(Traditional)
ATTN: Vanessa Powell PHONE NO : 818 4932734
15900 Valley View Court SE DECISION MADE: 17-MAR-20
Sylmar CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aluna
Knox Medical Diagnostics, Inc. 510(k) NO: K193311(Traditional)
ATTN: Charvi Shetty PHONE NO : 415 3200693
345 California Street, Suite 600 SE DECISION MADE: 25-MAR-20
San Francisco CA 94104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches
ProSys International Ltd 510(k) NO: K193325(Traditional)
ATTN: Graham Steer PHONE NO : 44 2089 447585
Suite 303, Highland House, 165 TheSE DECISION MADE: 13-MAR-20
Wimbledon GB SW19 1NE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve
Cardinal Health 200, LLC 510(k) NO: K193327(Traditional)
ATTN: Caroline Miceli PHONE NO : 312 2702012
3651 Birchwood Drive SE DECISION MADE: 20-MAR-20
Waukegan IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL + Diode Laser Machine
Beijing Globalipl Development Co.,510(k) NO: K193328(Traditional)
ATTN: Li Ye PHONE NO : 86 188 65721581
F-8 Qunyinghui Building, Jinyuan RSE DECISION MADE: 25-MAR-20
Beijing CN 102628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sherlock
Open Implants, LLC 510(k) NO: K193335(Traditional)
ATTN: Tamara Nazzal PHONE NO : 1 781 5873242
800 West Cummngs Ave, Suite 4900 SE DECISION MADE: 24-MAR-20
Woburn MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
Covidien, LLC 510(k) NO: K193356(Traditional)
ATTN: Juma Hoshino PHONE NO : 301 5306541
5920 Longbow Drive SE DECISION MADE: 02-MAR-20
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)
Beckman Coulter, Inc. 510(k) NO: K193358(Traditional)
ATTN: Elaine Duncan PHONE NO : 916 3743279
1584 Enterprise Blvd SE DECISION MADE: 03-MAR-20
West Sacramento CA 95630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 ICF
Stryker GmbH 510(k) NO: K193366(Traditional)
ATTN: Cindy Leon PHONE NO : 201 8315374
325 Corporate Drive SE DECISION MADE: 20-MAR-20
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: elysion-pro
High Technology Products SLU 510(k) NO: K193367(Traditional)
ATTN: Sergi Lozano PHONE NO : 934 588566
Pasaje Masoliver 24 SE DECISION MADE: 12-MAR-20
Barcelona ES 08005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TumEase Acupressure Bracelets
MumEase 510(k) NO: K193374(Traditional)
ATTN: Catherine Varley PHONE NO : 704 4990044
227 W 4th Street SE DECISION MADE: 04-MAR-20
Charlotte NC 28202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CarboClear Lumbar Cage System
CarboFix Orthopedics Ltd. 510(k) NO: K193378(Traditional)
ATTN: Hila Wachsler-Avrahami PHONE NO : 972 9 9511511
11 Ha'hoshlim St. SE DECISION MADE: 02-MAR-20
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vista Clear
Inter-Med / Vista Dental Products 510(k) NO: K193389(Traditional)
ATTN: Alex Johnson PHONE NO : 262 6315306
2200 South St. Ste. A SE DECISION MADE: 04-MAR-20
Racine WI 53404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).
Leica Biosystems Newcastle Ltd. 510(k) NO: K193393(Traditional)
ATTN: Matthew West PHONE NO : 44 191 2150567
Balliol Business Park West, BentonSE DECISION MADE: 06-MAR-20
Newcastle Upon Tyne GB NE12 8EW 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLthread PEEK Suture Anchor
Biomet Inc. 510(k) NO: K193402(Traditional)
ATTN: Haley Pioch PHONE NO : 412 3762510 214
56 East Bell Drive, PO Box 587 SE DECISION MADE: 05-MAR-20
Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine Skipjack System
SeaSpine Orthopedics Corporation 510(k) NO: K193418(Traditional)
ATTN: Aly Alvarez PHONE NO : 760 2165622
5770 Armada Drive SE DECISION MADE: 13-MAR-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pre-Milled Blank
Arum Dentistry Co. Ltd 510(k) NO: K193425(Traditional)
ATTN: Hwang-Heung Yeon PHONE NO : 82 42721 3644
1 Building, 44, Techno 8-ro SE DECISION MADE: 09-MAR-20
Yuseong-gu, Daejeon KR 34028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elite iQ
Cynosure LLC 510(k) NO: K193426(Traditional)
ATTN: Michael King PHONE NO : 781 9932454
5 Carlisle Road SE DECISION MADE: 09-MAR-20
Westford MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bare: 808
LUVO Medical Technologies, Inc 510(k) NO: K193446(Traditional)
ATTN: Gregory Berzak PHONE NO : 519 6203900
125 Fleming Dr SE DECISION MADE: 10-MAR-20
Cambridge CA N1T 2B8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vista Dyes
Inter-Med / Vista Dental Products 510(k) NO: K193447(Traditional)
ATTN: Alex Johnson PHONE NO : 262 6315306
2200 South St. Ste. A SE DECISION MADE: 11-MAR-20
Racine WI 53404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioNourish Lubricant
Good Clean Love, Inc. 510(k) NO: K193448(Traditional)
ATTN: Weny Strgar PHONE NO : 541 3444483
207 W 5th Avenue SE DECISION MADE: 12-MAR-20
Eugene OR 97401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruDi Probe
Acclarent, Inc. 510(k) NO: K193453(Traditional)
ATTN: Leena Sorathia PHONE NO : 1 949 9234118
31 Technology Drive SE DECISION MADE: 23-MAR-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tritium Sternal Cable Plate System
Pioneer Surgical Technology, Inc. 510(k) NO: K193468(Traditional)
ATTN: Linda Busklein PHONE NO : 906 2269909
375 River Park Circle SE DECISION MADE: 12-MAR-20
Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sternal Cable System
A&E Medical Corporation 510(k) NO: K193479(Traditional)
ATTN: Peter Browne PHONE NO : 732 3787337
5206 Asbury Road, PO Box 758 SE DECISION MADE: 23-MAR-20
Farmingdale NJ 07727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AeroNOx 2.0 Nitric Oxide Titration & Monitoring System
International Biomedical 510(k) NO: K193481(Special)
ATTN: Amy Pieper PHONE NO : 512 8730033
8206 Cross Park Drive SE DECISION MADE: 10-MAR-20
Austin TX 78754 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PrisMax System Version 3
Baxter Healthcare Corporation 510(k) NO: K193482(Traditional)
ATTN: Christopher Scavotto PHONE NO : 763 4634621
7601 Northland Drive SE DECISION MADE: 13-MAR-20
Brooklyn Park MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Epic 980
Biolase, Inc 510(k) NO: K193486(Traditional)
ATTN: Alicia Mszyca PHONE NO : 949 2268471
4 Cromwell SE DECISION MADE: 16-MAR-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Agilon Strip
Biogennix, LLC 510(k) NO: K193487(Traditional)
ATTN: Timothy Bumbalough PHONE NO : 949 2530994
1641 McGaw Ave. SE DECISION MADE: 30-MAR-20
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: restor3d Metallic Interference Screw
restor3D 510(k) NO: K193491(Traditional)
ATTN: Nathan Evans PHONE NO : 984 8880593
311 W Corporation St SE DECISION MADE: 19-MAR-20
Durham NC 27701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ViziShot 2 FLEX
Olympus Surgical Technologies Amer510(k) NO: K193517(Traditional)
ATTN: Mary Anne Patella PHONE NO : 508 8042600
136 Turnpike Road SE DECISION MADE: 18-MAR-20
Southborough MA 01772-2104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOSMOS
EchoNous, Inc. 510(k) NO: K193518(Traditional)
ATTN: Trish Liau PHONE NO : 425 4024044
8310 154th Ave NE, Bldg B, Ste 200SE DECISION MADE: 26-MAR-20
Redmond WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioFire Blood Culture Identification 2 (BCID2) Panel
BioFire Diagnostics, LLC 510(k) NO: K193519(Traditional)
ATTN: Kristen Kanack PHONE NO : 801 7366354 1330
515 Colorow Drive SE DECISION MADE: 18-MAR-20
Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SI-BONE iFuse Implant System®
Si-Bone, Inc 510(k) NO: K193524(Traditional)
ATTN: Susan Noriega PHONE NO : 650 7931966
47 El Camino Real, Suite 101 SE DECISION MADE: 31-MAR-20
Santa Clara CA 95050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS Abutment for MIS Conical Connection Implants
Dentsply Sirona 510(k) NO: K193529(Traditional)
ATTN: Karl Nittinger PHONE NO : 717 8494424
221 West Philadelphia Street, SuitSE DECISION MADE: 05-MAR-20
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Deklene MAXX
Teleflex Medical 510(k) NO: K193530(Special)
ATTN: Robin Haden PHONE NO : 919 4338046
3015 Carrington Mill Blvd SE DECISION MADE: 19-MAR-20
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON Anti-HAV Assay
DiaSorin Inc. 510(k) NO: K193532(Traditional)
ATTN: John C. Walter PHONE NO : 651 4399710
1951 Northwestern Ave SE DECISION MADE: 02-MAR-20
Stillwater MN 55082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)
Beckman Coulter, Inc 510(k) NO: K193536(Traditional)
ATTN: Elaine Duncan PHONE NO : 916 3743279
1584 Enterprise Blvd. SE DECISION MADE: 18-MAR-20
West Sacramento CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml
Thermo Fisher Scientific 510(k) NO: K193538(Traditional)
ATTN: Cynthia Knapp PHONE NO : 800 8718909 322411
1 Thermo Fisher Way SE DECISION MADE: 12-MAR-20
Oakwood Village OH 440146 510(k) STATEMENT
DEVICE: NuVasive Cohere Thoracolumbar Interbody System
NuVasive, Incorporated 510(k) NO: K193541(Traditional)
ATTN: Michelle Cheung PHONE NO : 858 9093360
7475 Lusk Blvd. SE DECISION MADE: 30-MAR-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEALICOIL Knotless Suture Anchors
Smith & Nephew, Inc. 510(k) NO: K193558(Traditional)
ATTN: Camille Black PHONE NO : 978 7491057
7135 Goodlett Farms Parkway SE DECISION MADE: 18-MAR-20
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner
Materialise NV 510(k) NO: K193560(Traditional)
ATTN: Veerle Vanderheyden PHONE NO : 32 16744571
Technologielaan 15 SE DECISION MADE: 20-MAR-20
Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)
BioMerieux, Inc. 510(k) NO: K193572(Traditional)
ATTN: Jolyn Tenllado PHONE NO : 314 7318386
595 Anglum Road SE DECISION MADE: 13-MAR-20
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PlasmaBlade X 3.0S LIGHT
Medtronic Navigation 510(k) NO: K193579(Traditional)
ATTN: Gina Cunsolo PHONE NO :
826 Coal Creek Circle SE DECISION MADE: 24-MAR-20
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster
Sri Trang Gloves (Thailand) Public510(k) NO: K193581(Abbreviated)
ATTN: Jarinya Jirojkul PHONE NO : 66 74 344677
10 SOi 10 Phetkasem Road SE DECISION MADE: 20-MAR-20
Hatyai TH 90110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SterilContainer S2 System
Aesculap, Inc. 510(k) NO: K193582(Traditional)
ATTN: Sierra Mertz PHONE NO : 610 9849076
3773 Corporate Parkway SE DECISION MADE: 17-MAR-20
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive 3DP Interfixated ALIF System
NuVasive, Incorporated 510(k) NO: K193593(Traditional)
ATTN: Jessica LeBlanc PHONE NO : 858 9093302
7475 Lusk Blvd. SE DECISION MADE: 25-MAR-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q Switched Nd: YAG Laser machine
Beijing Lead Beauty S & T Co., Ltd510(k) NO: K193609(Traditional)
ATTN: Jiao Zhang PHONE NO : 86 10 60418096
202, No.5 workshop, No.1 caida 3rdSE DECISION MADE: 20-MAR-20
Beijing CN 101300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMT Suture Delivery System
Applied Medical Technology, Inc. 510(k) NO: K193612(Traditional)
ATTN: Joy Tubero PHONE NO : 440 7174000
8006 Katherine Blvd. SE DECISION MADE: 12-MAR-20
Brecksville OH 44141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FINE Osteotomy around the knee
Bodycad Laboratories, Inc. 510(k) NO: K193614(Traditional)
ATTN: Guy Sevigny PHONE NO : 418 5271388
2035, rue du Haut-Bord SE DECISION MADE: 25-MAR-20
Quebec City CA G1N 4R7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NorthStar™ OCT Spinal System
SeaSpine Orthopedics Corporation 510(k) NO: K193615(Traditional)
ATTN: Alicia McArthur PHONE NO : 760 2165117
5770 Armada Drive SE DECISION MADE: 25-MAR-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIX Ankle System
Jeil Medical Corporation 510(k) NO: K193616(Special)
ATTN: Jonghwan Kim PHONE NO : 82 2850 3524
702, 703, 704, 705, 706, 804, 805,SE DECISION MADE: 04-MAR-20
Seoul KR 08378 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cry-Ac®, Cry-Ac-3®, Cry-Baby
Brymill Cryogenic Systems 510(k) NO: K193619(Traditional)
ATTN: Paul Sideleau PHONE NO : 800 7772796 103
105 Windermere Avenue, Suite 2B SE DECISION MADE: 25-MAR-20
Ellington CT 06029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable NIBP Cuff
Shenzhen Changke Connect Electroni510(k) NO: K193629(Traditional)
ATTN: Yahui Zhou PHONE NO : 86 136 13012560
A2-4th floor of Xiang dali TechnolSE DECISION MADE: 25-MAR-20
Longgang District, Shenzhen CN 51510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APTUS® Ankle Trauma System 2.8/3.5
Medartis AG 510(k) NO: K193633(Traditional)
ATTN: Andrea Kiefer-Schweizer PHONE NO : 41 61 6333434
Hochbergerstrasse 60E SE DECISION MADE: 26-MAR-20
Basel CH CH-4057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APTUS® Foot 2.8-3.5 System
Medartis AG 510(k) NO: K193639(Traditional)
ATTN: Andrea Kiefer-Schweizer PHONE NO : 41 61633 3434
Hochbergerstrasse 60E SE DECISION MADE: 26-MAR-20
Basel CH CH-4057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AbClose - Port Site Closure Device
Medeon Biodesign, Inc. 510(k) NO: K193652(Traditional)
ATTN: Tsung-Yu Hsieh PHONE NO : 886 2 28816686 130
7F, 116, HouGang St., SE DECISION MADE: 26-MAR-20
Taipei TW 11170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SkyPulse
Fotona d.o.o. 510(k) NO: K193656(Traditional)
ATTN: Marko Berdajs PHONE NO : 386 1 5009100
Stegne 7 SE DECISION MADE: 27-MAR-20
Ljubljana SI SI-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Viz ICH
Viz.ai, Inc. 510(k) NO: K193658(Traditional)
ATTN: Gregory Ramina PHONE NO : 239 8983105
555 De Haro St Suite 400 SE DECISION MADE: 18-MAR-20
San Francisco CA 94107 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iTero Element 5D
Align Technology, Inc. 510(k) NO: K193659(Traditional)
ATTN: Angela M. Frederickson PHONE NO : 650 3363887
2820 Orchard Parkway SE DECISION MADE: 20-MAR-20
San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LightWalker Laser System Family
Fotona d.o.o. 510(k) NO: K193661(Traditional)
ATTN: Marko Berdajs PHONE NO : 386 1 5009100
Stegne 7 SE DECISION MADE: 25-MAR-20
Ljubljana SI 1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shapiro MD model laser 272
Conversion Labs, PR, LLC 510(k) NO: K193667(Traditional)
ATTN: Stefan Galluppi PHONE NO : 866 3515907
53 Calle Las Palmeras, Suite 802 SE DECISION MADE: 25-MAR-20
San Juan PR 00901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Coronet Soft Tissue Fixation System
CoNextions Medical 510(k) NO: K200028(Traditional)
ATTN: Matthew Swift PHONE NO : 385 3511461
150 North Wright Brothers Drive SuSE DECISION MADE: 04-MAR-20
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AI-ECG Tracker
Shenzhen Carewell Electronics Co.,510(k) NO: K200036(Traditional)
ATTN: Chang Liu PHONE NO : 86 75586 170389
Floor 4, BLD 9, Baiwangxin High-TeSE DECISION MADE: 20-MAR-20
Shenzhen CN 518108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Universal Base Conical Connection (CC)
Nobel Biocare AG 510(k) NO: K200040(Traditional)
ATTN: Bernice Jim PHONE NO : 41 79 8550073
Balz Zimmermann-Strasse 7 SE DECISION MADE: 30-MAR-20
Kloten Zurich CH 8302 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlexPointer 1.5 Single Use, FlexTube 3 Single Use
Fiagon GmbH 510(k) NO: K200041(Special)
ATTN: Dirk Mucha PHONE NO : 49 3302 2012110
Neuendorfstrasse 23b SE DECISION MADE: 10-MAR-20
Hennigsdorf DE 16761 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range
Field Orthopaedics Pty Ltd 510(k) NO: K200043(Traditional)
ATTN: Kieran Leacy PHONE NO : 61 402 693021
375 Wickham Terrace SE DECISION MADE: 23-MAR-20
Spring Hill AU 4000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MectaLIF Anterior Simple
Medacta International SA 510(k) NO: K200048(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 09-MAR-20
Castel San Pietro CH ch-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Senhance Surgical System
TransEnterix, Inc. 510(k) NO: K200049(Traditional)
ATTN: Kaitlyn Alexander PHONE NO : 1 919 7658400 8505
635 Davis Drive, Suite 300 SE DECISION MADE: 09-MAR-20
Morrisville NC 27650 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable SpO2 Sensor
Shenzhen Changke Connect Electroni510(k) NO: K200069(Traditional)
ATTN: Yahui Zhou PHONE NO : 86 136 13012560
A2-4th floor of Xiang dali TechnolSE DECISION MADE: 13-MAR-20
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3DMetal Diaphyseal Femoral Cones
Medacta International SA 510(k) NO: K200075(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 13-MAR-20
Castel San Pietro CH 6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: speX LP Support Catheter
Reflow Medical 510(k) NO: K200094(Special)
ATTN: Krystal Santiago PHONE NO : 949 4810399
208 Avenida Fabricante #100 SE DECISION MADE: 18-MAR-20
San Clemente CA 92672 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Response BandLoc Spinal Fixation
OrthoPediatrics Corp. 510(k) NO: K200097(Traditional)
ATTN: Jackie Jaskula PHONE NO : 574 2670187
2850 Frontier Drive SE DECISION MADE: 16-MAR-20
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEO 1st MTP Joint Arthrodesis Plating System
Gramercy Extremity Orthopedics, LL510(k) NO: K200108(Traditional)
ATTN: Michael P. Simpson PHONE NO : 855 4362278
1239 N Glenville Dr SE DECISION MADE: 26-MAR-20
Richardson TX 75081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SANDRO Dual
WON TECH Co., Ltd. 510(k) NO: K200110(Traditional)
ATTN: Lana Hong PHONE NO : 82 70 78366970
64 Techno 8-Ro, Yuseong-gu SE DECISION MADE: 16-MAR-20
Daejeon KR 34028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINK TrabecuLink Tibial Cones
Waldemar Link GmbH & Co. KG 510(k) NO: K200113(Traditional)
ATTN: Stefanie Fuchs PHONE NO : 49 4053 995530
Oststrabe 4-10 SE DECISION MADE: 18-MAR-20
Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shear Wave Quantificational Ultrasound Diagnostic System
Wuxi Hisky Medical Technologies Co510(k) NO: K200136(Traditional)
ATTN: Jinhua Shao PHONE NO : 86 1082 151572
B401, 530 Plaza, University SciencSE DECISION MADE: 17-MAR-20
Wuxi CN 214135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Silhouette Instalift
Silhouette Lift Inc. 510(k) NO: K200140(Traditional)
ATTN: Anthony DiBernardo PHONE NO : 949 7272074
1 Technology Drive F211 SE DECISION MADE: 27-MAR-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill
Zimmer, Inc. 510(k) NO: K200151(Traditional)
ATTN: Pankti Shah PHONE NO : 574 3719830
1800 W. Center Street SE DECISION MADE: 17-MAR-20
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTS Omadacycline 0.002 - 32 ug/mL
Liofilchem s. r. l. 510(k) NO: K200180(Traditional)
ATTN: Fabio Brocco PHONE NO : 39 085 8930745
Via Scozia zona ind.le SE DECISION MADE: 20-MAR-20
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: CS 9600
Trophy 510(k) NO: K200183(Traditional)
ATTN: Marie-Pierre Labat-Camy PHONE NO : 33 16480 8500
4 Rue F. Pelloutier SE DECISION MADE: 13-MAR-20
Croissy Beaubourg FR 77435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WIRION
Cardiovascular Systems, Inc 510(k) NO: K200198(Traditional)
ATTN: Erika Huffman PHONE NO : 877 2740360
1225 Old Hwy 8 NW SE DECISION MADE: 18-MAR-20
Saint Paul MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Persona Personalized Knee System
Zimmer, Inc. 510(k) NO: K200209(Traditional)
ATTN: Gregory Foster PHONE NO : 574 3710519
1800 W. Center Street SE DECISION MADE: 24-MAR-20
Warsaw IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEA-LINK Anterior Cervical Plate System
Indius Medical Technologies Pvt. L510(k) NO: K200224(Traditional)
ATTN: Aditya Ingalhalikar PHONE NO : 91 839 0873873
Unit 12, Floors 1 and 2, ElectroniSE DECISION MADE: 24-MAR-20
Pune IN 411009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TempSure System
Cynosure LLC 510(k) NO: K200241(Traditional)
ATTN: Kevin O'Connell PHONE NO : 781 9932454
5 Carlisle Road SE DECISION MADE: 25-MAR-20
Westford MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUVUE (senofilcon A) Soft Contact Lens Multifocal
Johnson & Johnson Vision Care, Inc510(k) NO: K200243(Traditional)
ATTN: Scott Durland PHONE NO : 904 4433458
7500 Centurion Parkway, Suite 100 SE DECISION MADE: 17-MAR-20
Jacksonville FL 32256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Edwards eSheath Introducer Set
Edwards Lifesciences 510(k) NO: K200258(Traditional)
ATTN: Vilma Arechiga PHONE NO : 949 2503903
1 Edwards Way SE DECISION MADE: 09-MAR-20
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: L100 Go System
Bioness Inc. 510(k) NO: K200262(Special)
ATTN: Mercedes Bayani PHONE NO : 661 3626690
25103 Rye Canyon Loop SE DECISION MADE: 04-MAR-20
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Health Line CT Midline Catheter
Health Line International Corporat510(k) NO: K200263(Special)
ATTN: Aaron G Faulkner PHONE NO : 801 7737798
5675 W 300 S SE DECISION MADE: 12-MAR-20
Salt Lake City UT 84104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOSPA® IS™ Spinal Fixation System
Corentec Co., Ltd. 510(k) NO: K200267(Special)
ATTN: Sungwon Yang PHONE NO : 82 41 4107176
12, Yeongsanhong 1-gil, Ipjang-MyeSE DECISION MADE: 06-MAR-20
Cheonan-si KR 31056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sapphire II PRO
OrbusNeich Medical Trading Inc. 510(k) NO: K200269(Special)
ATTN: John Pazienza PHONE NO : 954 7300711
5363 NW 35th Avenue SE DECISION MADE: 04-MAR-20
Fort Lauderdale FL 33309 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OVision Imaging System
Ophthalmic Labs, Inc. 510(k) NO: K200275(Third Party - Traditional)
ATTN: Matthew Carnevale PHONE NO : 877 5108300
18 Berlin Ave SE DECISION MADE: 03-MAR-20
Milton MA 02186 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CytoCore
Praxis Medical, LLC 510(k) NO: K200278(Traditional)
ATTN: John Fisher PHONE NO : 813 5458607
500 N. Willow Ave. #101 SE DECISION MADE: 31-MAR-20
Tampa FL 33606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Gecko Spinal System
Ortho Development Corporation 510(k) NO: K200281(Traditional)
ATTN: Divya Palan PHONE NO : 801 6198922
12187 South Business Park Drive SE DECISION MADE: 31-MAR-20
Draper UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GrandioSO Light Flow
VOCO GmbH 510(k) NO: K200294(Special)
ATTN: M Th Plaumann PHONE NO : 49 472 17190
Anton-Flettner-Str. 1-3 SE DECISION MADE: 27-MAR-20
Cuxhaven DE 27472 510(k) STATEMENT
DEVICE: EPIQ Diagnostic Ultrasound System
Philips Ultrasound, Inc. 510(k) NO: K200304(Third Party - Traditional)
ATTN: Linda Schulz PHONE NO : 425 9081362
22100 Bothell Everett Highway SE DECISION MADE: 06-MAR-20
Bothell WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit
Abbott (formerly Thoratec Corporat510(k) NO: K200306(Special)
ATTN: Bindya Gadhia PHONE NO : 925 2275834
6035 Stoneridge Drive SE DECISION MADE: 06-MAR-20
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality
Stryker 510(k) NO: K200310(Special)
ATTN: April Malmborg PHONE NO : 408 7542473
5900 Optical Ct SE DECISION MADE: 06-MAR-20
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VersaWrap Tendon Protector
Alafair Biosciences Inc 510(k) NO: K200311(Special)
ATTN: Ben Walthall PHONE NO : 800 2065586
6101 W Courtyard Drive ste 2-225 SE DECISION MADE: 06-MAR-20
Austin TX 78730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Capere Thrombectomy System
Vascular Medcure, Inc. 510(k) NO: K200314(Special)
ATTN: Jeffrey P DuMontelle PHONE NO : 949 3784742
1500 S. Sunkist St. - Suite H SE DECISION MADE: 04-MAR-20
Anaheim CA 92806 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
Kyocera Medical Technologies, Inc.510(k) NO: K200328(Special)
ATTN: Anthony DeBenedictis PHONE NO : 909 5572360
1200 California St. Suite 210 SE DECISION MADE: 11-MAR-20
Redlands CA 92374 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rapid Acoustic Pulse Device
Soliton Inc. 510(k) NO: K200331(Special)
ATTN: Leslie Honda PHONE NO : 206 3758586
5304 Ashbrook Drive SE DECISION MADE: 10-MAR-20
Houston TX 77081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FloPatch (FP120)
Flosonics Medical (r/a 1929803 Ont510(k) NO: K200337(Third Party - Traditional)
ATTN: Andrew Eibl PHONE NO : 705 6266419
325 Front St W, Fourth Floor, OneESE DECISION MADE: 24-MAR-20
Toronto CA M5V 2Y1 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Arthrex FiberTak Suture Anchor
Arthrex Inc. 510(k) NO: K200341(Special)
ATTN: Jessica L. Singelais PHONE NO : 1 239 5984302 73091
1370 Creekside Boulevard SE DECISION MADE: 12-MAR-20
Naples, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation 510(k) NO: K200349(Traditional)
ATTN: Rachel Gilbert PHONE NO :
200 Prospect Street SE DECISION MADE: 13-MAR-20
Waltham MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula
Edwards Lifesciences LLC 510(k) NO: K200358(Special)
ATTN: Anna Califato PHONE NO : 949 2505083
One Edwards Way SE DECISION MADE: 13-MAR-20
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TrackX
Track X Technology, LLC 510(k) NO: K200360(Special)
ATTN: David Skwerer PHONE NO : 888 7872259
200 Timberhill Place, Suite 223 SE DECISION MADE: 05-MAR-20
Chapel Hill NC 27514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quidel Triage® TOX Drug Screen, 94600
Quidel Cardiovascular Inc. 510(k) NO: K200363(Special)
ATTN: Rachael S Williamson PHONE NO : 858 3020334
9975 Summers Ridge Road SE DECISION MADE: 11-MAR-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit
Centers For Disease Control And Pr510(k) NO: K200370(Special)
ATTN: Yon Yu PHONE NO : 404 6393046
1600 Clifton Rd; MS H24-11 SE DECISION MADE: 10-MAR-20
Atlanta GA 30329 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Super Sheath
TOGO MEDIKIT CO., LTD. 510(k) NO: K200379(Special)
ATTN: Daisuke Nagamizu PHONE NO : 011 81 982538000
17148-6 Aza Kamekawa, Oaza HichiyaSE DECISION MADE: 19-MAR-20
Hyuga City JP 883-0062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTINUUM PACS
Integrated Ophthalmic Systems, Inc510(k) NO: K200385(Third Party - Traditional)
ATTN: Matthew Carnevale PHONE NO : 877 2630003
596 Main Street SE DECISION MADE: 16-MAR-20
Woburn MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Insight Enhanced DRF Digital Imaging System
Imaging Engineering, LLC 510(k) NO: K200396(Special)
ATTN: George Jachode PHONE NO : 239 2231371
1318 NW 7th Ave SE DECISION MADE: 06-MAR-20
Cape Coral FL 33993 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Evolve Breast Pump
Hygeia II Medical Group, Inc. 510(k) NO: K200406(Special)
ATTN: Brett Nakfoor PHONE NO : 714 5157571
6241 Yarrow Drive SE DECISION MADE: 18-MAR-20
Carlsbad CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEGION Inserts with JRNY Lock
Smith & Nephew, Inc. 510(k) NO: K200407(Special)
ATTN: Konrad Wolfmeyer PHONE NO : 901 3991367
7135 Goodlett Farms Parkway SE DECISION MADE: 13-MAR-20
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVIX-S VW
Vieworks Co., Ltd. 510(k) NO: K200418(Traditional)
ATTN: Jordin Kim PHONE NO : 82 4 4961859
41-3, Burim-ro 170beon-gil, SE DECISION MADE: 18-MAR-20
Anyang-si KR 14055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iBalance UKA Tibial Tray Implant
Arthrex Inc. 510(k) NO: K200433(Special)
ATTN: Ivette Galmez PHONE NO : 239 6435553 71263
1370 Creekside Boulevard SE DECISION MADE: 17-MAR-20
Naples FL 34108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit
Hologic, Inc. 510(k) NO: K200436(Special)
ATTN: Jill Wyland PHONE NO : 858 4108487
10210 Genetic Center Drive SE DECISION MADE: 23-MAR-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoTool IV 1.10
Monarch Medical Technologies, LLC 510(k) NO: K200443(Third Party - Traditional)
ATTN: Ann Marie Gaitan PHONE NO : 1 704 5620777
4400 Stuart Andrew Blvd, Suite N SE DECISION MADE: 17-MAR-20
Charlotte NC 28217 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Trigger Switch and Cord
New Deantronics Taiwan, Ltd. 510(k) NO: K200455(Traditional)
ATTN: Jane Liu PHONE NO : 8862 22681726
12F, No. 51, Sec. 4, Chong Yang RoSE DECISION MADE: 31-MAR-20
New Taipei City TW 23675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Becker External Drainage and Monitoring System
Medtronic, Inc. 510(k) NO: K200456(Special)
ATTN: Nancy Hampton PHONE NO : 949 4903773
125 Cremona Drive SE DECISION MADE: 26-MAR-20
Goleta CA 93117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Symbia 6.7
Siemens Medical Solutions USA, Inc510(k) NO: K200474(Special)
ATTN: Cynthia Busch PHONE NO : 847 6436818
2501 N Barrington Road SE DECISION MADE: 20-MAR-20
Hoffman Estates IL 60192-2061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StimRouter Neuromodulation System
Bioness Inc. 510(k) NO: K200482(Special)
ATTN: Sageev George PHONE NO : 661 9025336
25103 Rye Canyon Loop SE DECISION MADE: 27-MAR-20
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RadiForce RX1270, RadiForce RX1270-AR
EIZO Corporation 510(k) NO: K200485(Abbreviated)
ATTN: Hiroaki Hashimoto PHONE NO : 81 76 2742468
153 Shimokashiwano SE DECISION MADE: 23-MAR-20
Hakusan JP 924-8566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover
Stryker Corporation 510(k) NO: K200493(Traditional)
ATTN: Corinne Larke-Grass PHONE NO : 269 2541554
4100 E. Milham Avenue SE DECISION MADE: 21-MAR-20
Kalamazoo MI 49001 510(k) STATEMENT
DEVICE: CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES
GE Healthcare 510(k) NO: K200494(Special)
ATTN: Joel Kent PHONE NO : 617 8510943
8200 West Tower Avenue SE DECISION MADE: 29-MAR-20
Milwaukee WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QuickDraw Venous Cannula
Edwards Lifesciences LLC 510(k) NO: K200499(Special)
ATTN: Diem My Nguyen PHONE NO : 949 2505124
One Edwards Way SE DECISION MADE: 29-MAR-20
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.CT Cardiac Planning
Siemens Medical Soultions USA, Inc510(k) NO: K200515(Special)
ATTN: Veronica Padharia PHONE NO : 630 8775761
2501 N Barrington Road SE DECISION MADE: 25-MAR-20
Hoffman Estates IL 60192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AERO CHROME* Breathable Performance Surgical Gowns
O&M Halyard, Inc 510(k) NO: K200522(Abbreviated)
ATTN: Kimberly Lewis PHONE NO : 470 2804388
9120 Lockwood Blvd SE DECISION MADE: 16-MAR-20
Mechanicsville VA 23116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System
Nexxt Spine LLC 510(k) NO: K200543(Special)
ATTN: Andy Elsbury PHONE NO : 317 4367801
14425 Bergen Blvd, Suite B SE DECISION MADE: 23-MAR-20
Noblesville IN 46060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUBEScan BioCon-1100
Mcube Technology Co., Ltd. 510(k) NO: K200548(Third Party - Traditional)
ATTN: Hye-Ri Choi PHONE NO : 82 02 34217780
#803, 123, Bonghwasan-ro Jungnang-SE DECISION MADE: 27-MAR-20
Seoul KR 02048 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AquaFlate Pre-Filled Sterile Water Syringe 10mL
HR Pharmaceuticals, Inc. 510(k) NO: K200556(Third Party - Traditional)
ATTN: Colby Wiesman PHONE NO : 717 2521110
2600 Eastern Boulevard, Suite 201 SE DECISION MADE: 31-MAR-20
York PA 17402 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Tablo Hemodialysis System
Outset Medical, Inc. 510(k) NO: K200741(Traditional)
ATTN: Jennifer Mascioli-Tudor PHONE NO : 650 3363222
1830 Bering Drive SE DECISION MADE: 31-MAR-20
San Jose CA 95112 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 275
TOTAL WITH SUMMARIES 264
TOTAL WITH STATEMENTS 11
