510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD April 2020
DEVICE: Solax Powered Wheelchair (Models: S7101, S7103)
Dongguan Prestige Sporting Goods C510(k) NO: K182400(Traditional)
ATTN: Zhang Zhao PHONE NO : 86 1376 3128800
3rd Ind. District, Qiatou Area, HoSE DECISION MADE: 14-APR-20
Dongguan CN 523950 510(k) STATEMENT
DEVICE: Zircos-Com
Bioden Co., Ltd 510(k) NO: K190139(Traditional)
ATTN: Kim Hye Min PHONE NO : 82 2 62922840
#B-803 119, Gasan digital 1-ro, GeSE DECISION MADE: 24-APR-20
Seoul KR 08589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac
Residential Home Sleep Services 510(k) NO: K190353(Traditional)
ATTN: Chris Gillette PHONE NO : 269 9634118
4602 Beckley Road SE DECISION MADE: 10-APR-20
Battle Creek MI 49015-7932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Forehead Thermometer
Xiamen Ants Bro Technology Co., Lt510(k) NO: K190984(Traditional)
ATTN: Jane Xu PHONE NO : 86 592 6537633
4th & 5th Floor, No.5 Building, TeSE DECISION MADE: 22-APR-20
Xiamen CN 361026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venus VivaTM
Venus Concept USA Inc. 510(k) NO: K191065(Traditional)
ATTN: Yoni Iger PHONE NO : 888 9070115
1880 N Commerce Pkwy, Suite 2 SE DECISION MADE: 01-APR-20
Weston FL 33326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Optimotion Blue Total Knee System
Optimotion Implants, LLC 510(k) NO: K191084(Traditional)
ATTN: Dan Justin PHONE NO : 435 8815742
5931 Brick Court, Suite 130 SE DECISION MADE: 07-APR-20
Winter Park FL 32792 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U-Aligner
Universal Orthodontic Laboratory I510(k) NO: K191308(Traditional)
ATTN: Jiahe Li PHONE NO : 562 4840700
11917 Front St. SE DECISION MADE: 23-APR-20
Norwalk CA 90650 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMET Lumbar Interbody Fusion Cage
BAUI Biotech Co., Ltd. 510(k) NO: K191353(Traditional)
ATTN: Jessy Lin PHONE NO : 886 2 89769538 153
6F.,No.8, Sec.1, Zongxing Rd., WugSE DECISION MADE: 14-APR-20
New Taipei City TW 24872 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neural Navigator
Soterix Medical, Inc. 510(k) NO: K191422(Traditional)
ATTN: Abhishek Datta PHONE NO : 888 9908327
237 W 35 ST, 1401 SE DECISION MADE: 06-APR-20
New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Maxxi Position Sensor
Neurovirtual USA, INC. 510(k) NO: K191492(Traditional)
ATTN: Eduardo Faria PHONE NO : 786 6938200
3303 W Commercial Blvd #100 SE DECISION MADE: 24-APR-20
Fort Lauderdale FL 33309 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OxSAT 100
S.L.P. Ltd. 510(k) NO: K191574(Traditional)
ATTN: Avi Yosef PHONE NO : 972 3 6870640 105
62 Anilewicz Street SE DECISION MADE: 09-APR-20
Tel-Aviv IL 67060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILICONE Personal Lubricant
Bath Concept Cosmetics (Dongguan) 510(k) NO: K191654(Traditional)
ATTN: Jack Yin PHONE NO : 86 769 22776878
No.2, Dushang Industrial Zone, DaFSE DECISION MADE: 14-APR-20
Dongguan CN 523052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRUIS Software Suite
Mechanodontics, Inc. 510(k) NO: K191720(Traditional)
ATTN: Mehdi Roein-Peikar PHONE NO : 888 7558320
11110 Ohio Avenue Ste 206 SE DECISION MADE: 17-APR-20
Los Angeles CA 90025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magnetic Surgical System
Levita Magnetics International Cor510(k) NO: K191762(Traditional)
ATTN: Alberto Rodrigues-Navarro PHONE NO : 650 2410320
1730 S. Amphlett Blvd, Suite 240 SE DECISION MADE: 01-APR-20
San Mateo CA 94402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orthopedic Fixation Pin
Tinavi (Anhui) Medical Technologie510(k) NO: K191803(Traditional)
ATTN: Jianhua Jiang PHONE NO : 86 55165 6052008401
Building 5,Robot Industrial Base oSE DECISION MADE: 14-APR-20
Hefei CN 230601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M-Vizion Femoral Revision System Extension
Medacta International SA 510(k) NO: K191816(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 29-APR-20
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GelPOINT Mini Advanced Access Platform
Applied Medical 510(k) NO: K191866(Traditional)
ATTN: Frans VandenBroek PHONE NO : 949 7138269
22872 Avenida Empresa SE DECISION MADE: 29-APR-20
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLAS Plating System
MiRus, LLC 510(k) NO: K191867(Traditional)
ATTN: Jordan Bauman PHONE NO : 678 3246272
2150 Newmarket Parkway, Suite 108 SE DECISION MADE: 09-APR-20
Marietta GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo Centroid System
Masimo Corporation 510(k) NO: K191882(Traditional)
ATTN: Linus Park PHONE NO : 949 2977000
52 Discovery SE DECISION MADE: 22-APR-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Standard Bougie
Standard Bariatrics 510(k) NO: K191885(Traditional)
ATTN: Alison Sathe PHONE NO : 513 3047971
4362 Glendale Milford Rd. SE DECISION MADE: 08-APR-20
Cincinnati OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 7 mm Extended Length Endoscope
Maquet Cardiovascular, LLC 510(k) NO: K191930(Traditional)
ATTN: Mark Dinger PHONE NO : 973 7097691
45 Barbour Pond Drive SE DECISION MADE: 15-APR-20
Wayne NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nautilus Smart ECMO Module
MC3 Incorporated 510(k) NO: K191935(Traditional)
ATTN: Adam Viitala PHONE NO : 734 9959089
2555 Bishop Circle W SE DECISION MADE: 09-APR-20
Dexter MI 48130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser Hair Removal System
Beijing Sano Laser S&T Development510(k) NO: K191970(Traditional)
ATTN: Hongbo Zhang PHONE NO : 86 105 7150601
Room 7-201, No.1, Caida 3rd StreetSE DECISION MADE: 06-APR-20
Bejing CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PELNAC Bilayer Wound Matrix
Gunze Limited 510(k) NO: K191992(Traditional)
ATTN: Hidenori Nishioka PHONE NO : 81 773 428035
46 Natsumegaichi, Aono SE DECISION MADE: 29-APR-20
Ayabe, Kyoto JP 623-8513 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S4 Screw System
Subchondral Solutions, Inc. 510(k) NO: K191995(Traditional)
ATTN: Sheryl McCoy PHONE NO : 408 8919604
147 Hillbrook Drive SE DECISION MADE: 18-APR-20
Los Gatos CA 95032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FAICO CMF System
FAICO Medical LLC 510(k) NO: K191997(Traditional)
ATTN: Heman Dario Fernandez PHONE NO : 54 11 45682599
9689 Parkview Ave. SE DECISION MADE: 22-APR-20
Boca Raton FL 33428 510(k) STATEMENT
DEVICE: SIRION Lateral Lumbar Interbody System
Astura Medical, LLC 510(k) NO: K192006(Traditional)
ATTN: Parker Kelch PHONE NO : 760 8148047
3168 Lionshead Ave, Suite 100 SE DECISION MADE: 02-APR-20
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTICALE® Cervical System
Silony Medical GmbH 510(k) NO: K192013(Traditional)
ATTN: Melanie Lubjuhn PHONE NO : 49 711 7825250
Leinfelder StraBe 60 SE DECISION MADE: 07-APR-20
Leinfelden-Echterdingen DE 70771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Faico Dental Implant System
FAICO Medical LLC 510(k) NO: K192015(Traditional)
ATTN: Hernan Dario Fernandez PHONE NO : 54 11 45682599
9689 Parkview Ave SE DECISION MADE: 03-APR-20
Boca Raton FL 33428 510(k) STATEMENT
DEVICE: Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
Fresenius Medical Care Renal Thera510(k) NO: K192017(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 6994479
920 Winter Street SE DECISION MADE: 24-APR-20
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc
Pathway, LLC 510(k) NO: K192034(Traditional)
ATTN: David Stroup PHONE NO : 619 4150103
8779 Cottonwood Avenue, Suite 105 SE DECISION MADE: 21-APR-20
Santee CA 92071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PGDx elio tissue complete
Personal Genome Diagnostics 510(k) NO: K192063(Traditional)
ATTN: Jennifer Dickey PHONE NO : 443 6028833
2809 Boston Street, Suite 503 SE DECISION MADE: 24-APR-20
Baltimore MD 21224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-ED COIL
Kaneka Pharma America LLC 510(k) NO: K192068(Traditional)
ATTN: Kazuhiko Inoue PHONE NO : 212 7054343
546 Fifth Avenue 21st Floor SE DECISION MADE: 25-APR-20
New York NY 10036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Droplet Pen Needle 34G
HTL-Strefa S.A 510(k) NO: K192082(Traditional)
ATTN: Aleksandra Prazmowska-WilanPHONE NO : 48 42 2700010
Adamowek 7 SE DECISION MADE: 21-APR-20
Ozorkow PL 95-035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exactech® Equinoxe® Stemless Humeral Components
Exactech, Inc. 510(k) NO: K192097(Traditional)
ATTN: Zach Sharrah PHONE NO : 352 3771140
SE DECISION MADE: 29-APR-20
Gainsville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System
Medax Srl Unipersonale 510(k) NO: K192099(Traditional)
ATTN: Stefano Cavalieri PHONE NO : 39 0535 1813915
Via R.Piva, 1/A SE DECISION MADE: 02-APR-20
Poggio Rusco IT 46025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medone Ultra, Medextra
Medax Srl Unipersonale 510(k) NO: K192101(Traditional)
ATTN: Stefano Cavalieri PHONE NO : 39 0535 1813915
Via R.Piva, 1/A SE DECISION MADE: 02-APR-20
Poggio Rusco IT 46025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Panthera Dental Milled Bars
Panthera Dental Inc. 510(k) NO: K192108(Abbreviated)
ATTN: Martine Fortin PHONE NO : 418 5270388
2035 rue du Haut-Bord SE DECISION MADE: 08-APR-20
Quebec city CA G1n 4N7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rejuvapen NXT
Refine USA LLC 510(k) NO: K192138(Traditional)
ATTN: Brian Smith PHONE NO : 866 5905533
340 3rd Avenue South Suite C SE DECISION MADE: 09-APR-20
Jacksonville Beach FL 32250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Galileo Vertebral Body Replacement Device
Bright Spine 510(k) NO: K192145(Traditional)
ATTN: Robert Simonson PHONE NO : 561 2899378
799 NE 71st Street SE DECISION MADE: 21-APR-20
Boca Raton FL 33487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rio Vial-to-Bag Drug Reconstitution Device
ICU Medical 510(k) NO: K192154(Traditional)
ATTN: Sheila Antonio PHONE NO : 949 3595708
951 Calle Amanecer SE DECISION MADE: 20-APR-20
San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CuraRad-ICH
CuraCloud Corp. 510(k) NO: K192167(Traditional)
ATTN: Xiaoxiao Liu PHONE NO : 206 5081036
999 Third Ave, Suite 700 SE DECISION MADE: 13-APR-20
Seattle WA 98104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PulsioFlex Monitoring System with ProAQT Sensor
Pulsion Medical Systems SE 510(k) NO: K192169(Traditional)
ATTN: Tobias Klaempfl PHONE NO : 49 8945 99140
Hans-Riedl-Str. 17 SE DECISION MADE: 30-APR-20
Feldkirchen DE 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IntelePACS
Intelerad Medical Systems Incorpor510(k) NO: K192176(Traditional)
ATTN: Luce Caron PHONE NO : 514 9316222 7307
800 Boul. De Maisonneuve Est., 12tSE DECISION MADE: 02-APR-20
Montreal CA H2L4L8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RocaTub Ureteral Catheter
Promepal Sam 510(k) NO: K192183(Traditional)
ATTN: Mohamed Rekik PHONE NO : 377 97 984244
9 Avenue Albert II SE DECISION MADE: 23-APR-20
Monaco MC 98000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magicore II System
InnoBioSurg Co., Ltd. 510(k) NO: K192197(Traditional)
ATTN: Eun-Ji Yoo PHONE NO : 82 42 9332879
44-19, Techno 10-ro, Yuseong-gu SE DECISION MADE: 28-APR-20
Daejeon KR 34027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant
CS Medical L.L.C. 510(k) NO: K192228(Traditional)
ATTN: Kendall Ashe PHONE NO : 919 2559472
2179 East Lyon Station Road SE DECISION MADE: 01-APR-20
Creedmoor NC 27522 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MF SAFECATH
MediFirst Co., Ltd. 510(k) NO: K192230(Traditional)
ATTN: Ha Tae Joo PHONE NO : 82 41 5222650
#1049-16, Charyeonggogae-ro, GwangSE DECISION MADE: 23-APR-20
Cheonan-si KR 31223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biowy PICC Catheter S Kit
Biowy Corporation 510(k) NO: K192246(Traditional)
ATTN: Arthur Lu PHONE NO : 1 949 3058211
27031/27002 Vista Terrace SE DECISION MADE: 30-APR-20
Lake Forest CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown
Xuchang Zhengde Environstar Medica510(k) NO: K192290(Traditional)
ATTN: Johnny Johnny PHONE NO : 86 374719 2078
NO.3 Weilai Road, Industry ClusterSE DECISION MADE: 30-APR-20
Xuchang CN 461200 510(k) STATEMENT
DEVICE: Medical Non-Ablative Fractional Laser Systems
Wingderm Electro-Optics Ltd. 510(k) NO: K192350(Traditional)
ATTN: Zhou Juan PHONE NO : 86 579871 28717
Rm 312, Building D-3, Dongsheng ScSE DECISION MADE: 30-APR-20
Beijing CN 100192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pressure Therapy System PT1003
Xiamen Senyang Co., Ltd. 510(k) NO: K192358(Traditional)
ATTN: Nina Cai PHONE NO : 086 592599 7502
4-5 Floor, Xingbei Industry, No 95SE DECISION MADE: 23-APR-20
Xinglin Xiamen CN 361000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CapKlenZ
Star Mountain Medical, Inc. 510(k) NO: K192382(Traditional)
ATTN: Aaron Chiu PHONE NO : 915 7744324
9005 Montana Ave, Suite A SE DECISION MADE: 20-APR-20
El Paso TX 79925 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann Screw-Retained Abutments
Straumann USA, LLC 510(k) NO: K192401(Traditional)
ATTN: Jennifer M Jackson PHONE NO : 978 7472509
60 Minuteman Road SE DECISION MADE: 06-APR-20
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Custodiol HTK Solution
Dr. Franz Kohler Chemie GmbH 510(k) NO: K192408(Traditional)
ATTN: Clifton Czarnojon PHONE NO : 49 6251 10830
Werner-von-Siemens-Strabe 14-28 SE DECISION MADE: 24-APR-20
Bensheim DE 64625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QwikCheck Chemical Indicators
Serim Research Corporation 510(k) NO: K192445(Traditional)
ATTN: Jackie Nelson PHONE NO :
3506 Reedy Drive SE DECISION MADE: 02-APR-20
Elkhard IN 46514 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NemoFAB
Software Nemotec S.L. 510(k) NO: K192475(Traditional)
ATTN: Carlos Arias PHONE NO : 34 91 4335222
Juan de la Cierva Street, 66 SE DECISION MADE: 23-APR-20
Arroyomolinos, Madrid ES 28939 510(k) STATEMENT
DEVICE: EL CAPITAN Anterior Lumber Interbody System
Astura Medical, LLC 510(k) NO: K192492(Traditional)
ATTN: Parker Kelch PHONE NO : 760 8148047
3186 Lionshead Ave, Suite 100 SE DECISION MADE: 21-APR-20
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Injector
Olympus Medical Systems Corp. 510(k) NO: K192498(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-machi SE DECISION MADE: 28-APR-20
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
Honsun(Nantong)Co.,Ltd 510(k) NO: K192500(Traditional)
ATTN: Iris Du PHONE NO : 86 0513 80580127
No.8, Tongxing Road, Nantong EconoSE DECISION MADE: 06-APR-20
Nantong CN 226009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient Monitor
Edan Instruments, Inc. 510(k) NO: K192514(Traditional)
ATTN: Alice Yang PHONE NO : 86 755 26858736
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 02-APR-20
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Psychemedics Microplate EIA for Cotinine in Hair
Psychemedics Corporation 510(k) NO: K192517(Traditional)
ATTN: Virginia Hill PHONE NO : 310 2167776
5832 Uplander Way SE DECISION MADE: 22-APR-20
Culver City CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Irradiation Cosmetic Device
Chongqing Peninsula Medical Techno510(k) NO: K192552(Traditional)
ATTN: Zhang Sudi PHONE NO : 86 150 12578550
No.2-4, 2F BLK1, Biological and BiSE DECISION MADE: 17-APR-20
Jiulongpo District CN 404100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter
MIVI Neurovascular 510(k) NO: K192558(Traditional)
ATTN: Janel Hurtado PHONE NO : 612 5185800
6545 City West Parkway SE DECISION MADE: 06-APR-20
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-EYE System
SMART Medical Systems Ltd. 510(k) NO: K192588(Traditional)
ATTN: Adva Yoselzon PHONE NO : 972 9 7444321
5 HaNofar St. SE DECISION MADE: 15-APR-20
Raanana IL 4366404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Globalcare Blood Pressure Monitor
Globalcare Medical Technology Co.,510(k) NO: K192609(Traditional)
ATTN: Janice Deng PHONE NO : 86 760 22589901
No.7 Factory, European Industrial SE DECISION MADE: 21-APR-20
Xiaolan Town, Zhongshan City CN 5510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)
Medtronic, Inc. 510(k) NO: K192636(Traditional)
ATTN: Nancy Cameron PHONE NO : 763 5262355
8200 Coral Sea St NE SE DECISION MADE: 08-APR-20
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GM501 SpermAir and GM501 SpermActive
Hamilton Thorne Incorporated 510(k) NO: K192644(Traditional)
ATTN: Donald Fournier PHONE NO : 1 978 9212050
100 Cummings Center, Suite 465E SE DECISION MADE: 23-APR-20
Beverly MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMPHONY™ OCT System
Medos International SARL 510(k) NO: K192646(Traditional)
ATTN: Sheree Geller PHONE NO : 508 8283291
Chemin-Blanc 38 SE DECISION MADE: 02-APR-20
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Manual Wheelchair
Jerry Medical Instrument (Shanghai510(k) NO: K192658(Traditional)
ATTN: Jianguo Chen PHONE NO : 86 138 17397985
Building 12, No. 615 Fengdeng Rd, SE DECISION MADE: 01-APR-20
Shanghai CN 201801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Introcan Safety 2 IV Catheter 18-24 gauge
B. Braun Medical Inc. 510(k) NO: K192676(Traditional)
ATTN: Tracy Larish PHONE NO : 610 5962941
901 Marcon Blvd. SE DECISION MADE: 01-APR-20
Allentown PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use
Gemtier Medical (Shanghai) Inc. 510(k) NO: K192679(Traditional)
ATTN: Lenny Cao PHONE NO : 86 21 67360886
No.18 Jianding Road, Fengjing TownSE DECISION MADE: 10-APR-20
Shanghai CN 201502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIBS (Digital Indirect Bonding System)
OrthoSelect, LLC 510(k) NO: K192701(Traditional)
ATTN: Steven N. Gardner PHONE NO : 801 7635039
831 E 340 S Suite 170 SE DECISION MADE: 21-APR-20
American Fork UT 84003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Osom Ultra Plus Flu A&B Test Kit
Sekisui Diagnostics, LLC 510(k) NO: K192719(Dual Track)
ATTN: Nisha Li PHONE NO : 858 7772668
6659 Top Gun Street SE DECISION MADE: 03-APR-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser Hair Removal Machine
Beijing Lead Beauty S & T Co., Ltd510(k) NO: K192735(Traditional)
ATTN: Jiao Zhang PHONE NO : 86 10 60418096
202, No.5 workshop, No.1 caida 3rdSE DECISION MADE: 03-APR-20
Beijing CN 101300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UroLift System Procedure Kit Sterilization Tray
NeoTract, Inc. 510(k) NO: K192781(Traditional)
ATTN: Brian Gall PHONE NO : 925 3296547
4155 Hopyard Rd. SE DECISION MADE: 14-APR-20
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gatekeeper Balloon Catheter
Arch Catheter, LLC 510(k) NO: K192786(Traditional)
ATTN: Michael Zhadkevich PHONE NO : 864 6802568
621 Grand Harbor Boulevard SE DECISION MADE: 25-APR-20
Ninety Six SC 29666 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci Xi Surgical System, da Vinci X Surgical System
Intuitive Surgical 510(k) NO: K192803(Traditional)
ATTN: Crystal Ong PHONE NO : 408 5238636
1266 Kifer Road SE DECISION MADE: 29-APR-20
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Duo-Flow Side x Side Double Lumen Catheter
Medical Components Inc. (dba MedCo510(k) NO: K192807(Traditional)
ATTN: Courtney Nix PHONE NO : 215 2564201
1499 Delp Drive SE DECISION MADE: 23-APR-20
Harleysville PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MECTA Sigma
Mecta Corporation 510(k) NO: K192834(Special)
ATTN: Robin Nicol PHONE NO : 503 6126780
19799 SW 95th Ave. SE DECISION MADE: 26-APR-20
Tualatin OR 97062 510(k) STATEMENT
DEVICE: Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
Spectrum Medical Ltd 510(k) NO: K192838(Traditional)
ATTN: Colleen Powell PHONE NO : 440 124238 7082
Harrier 4, Meteor Business Park, CSE DECISION MADE: 13-APR-20
Gloucester GB GL2 9QL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
Qura S.r.l. 510(k) NO: K192850(Traditional)
ATTN: Raffaella Tommasini PHONE NO : 39 0535 180305
Via di Mezzo, 23 SE DECISION MADE: 13-APR-20
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MT One
M&T SRL 510(k) NO: K192856(Traditional)
ATTN: Fiorenzo Rossi PHONE NO : 39 05 41727486
Via Pietrarubbia, 32/F SE DECISION MADE: 24-APR-20
Rimini IT 47900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Philips Biosensor BX100
Philips Medical Systems 510(k) NO: K192875(Traditional)
ATTN: Suzanne Goodman PHONE NO : 919 6086082
2 Canal Park SE DECISION MADE: 16-APR-20
Cambridge MA 02141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TwitchView System
Blink Device Company 510(k) NO: K192958(Special)
ATTN: Justin Hulvershorn PHONE NO : 206 2953372
1530 Westlake Ave N Suite 600 SE DECISION MADE: 02-APR-20
Seattle WA 98109 510(k) STATEMENT
DEVICE: KY Grosz UltraGel
RB Health (US) LLC 510(k) NO: K192982(Traditional)
ATTN: Elizabeth Viguerie PHONE NO : 1 973 4042600
399 Interpace Parkway SE DECISION MADE: 14-APR-20
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use
Medline Industries, Inc. 510(k) NO: K192988(Traditional)
ATTN: Jennifer Mason PHONE NO :
Three Lakes Drive SE DECISION MADE: 01-APR-20
Northfield IL 60030 510(k) STATEMENT
DEVICE: Visera Elite II Video System Center, Visera Elite II Endoeye 3D
Olympus Medical Systems Corp. 510(k) NO: K193026(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 03-APR-20
Hachioji-Shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
DeRoyal Industries, Inc. 510(k) NO: K193027(Traditional)
ATTN: Sarah Bennett PHONE NO : 865 3626112
200 DeBusk Lane SE DECISION MADE: 02-APR-20
Powell TN 37849 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KY Grosz Liquid
RB Health (US) LLC 510(k) NO: K193032(Traditional)
ATTN: Elizabeth Viguerie PHONE NO : 973 4042600
399 Interpace Parkway SE DECISION MADE: 20-APR-20
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GSI Audera Pro
Grason Stadler 510(k) NO: K193033(Traditional)
ATTN: Brent Nissly PHONE NO : 800 7002282
10395 West 70th Street SE DECISION MADE: 24-APR-20
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bevel Up Holder
NSP Tech Pte Ltd 510(k) NO: K193074(Traditional)
ATTN: HC TAN PHONE NO : 65 67478817
10 Admiralty Street, Northlink BuiSE DECISION MADE: 21-APR-20
Singapore SG 757695 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ambu aScope 4 Cysto
Ambu A/S 510(k) NO: K193095(Traditional)
ATTN: Anita Fjaestad PHONE NO : 45 7225 2000
Baltorpbakken 13 SE DECISION MADE: 02-APR-20
Ballerup DK 2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unified Arrhythmia Diagnostic System PocketECG IV
Medicalgorithmics S.A. 510(k) NO: K193104(Special)
ATTN: Marek Dziubinski PHONE NO : 48 22 8251249
Aleje Jerozolimskie 81 SE DECISION MADE: 09-APR-20
Warsaw PL 02-001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unicel DxH 800 Coulter Cellular Analysis System
Beckman Coulter 510(k) NO: K193124(Traditional)
ATTN: Samy Puccio PHONE NO : 305 3804509
11800 SW 147th Ave SE DECISION MADE: 16-APR-20
Miami FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIRA-C Integrated Fixation System
Camber Spine Technologies 510(k) NO: K193153(Traditional)
ATTN: Daniel Pontecorvo PHONE NO : 484 4204286
501 Allendale Road SE DECISION MADE: 24-APR-20
King of Prussia PA 19406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pristine Scope
Pristine Surgical 510(k) NO: K193161(Traditional)
ATTN: Stewart B. Davis PHONE NO : 603 2065597
Brady Sullivan Tower, 6th Floor, 1SE DECISION MADE: 21-APR-20
Manchester NH 03104 510(k) STATEMENT
DEVICE: Serranator PTA Serration Balloon Catheter
Cagent Vascular, LLC 510(k) NO: K193181(Traditional)
ATTN: Carol Burns PHONE NO : 610 6882006
150 Strafford Avenue #315 SE DECISION MADE: 15-APR-20
Wayne PA 19087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QuickClear Mechanical Thrombectomy System 6F- Straight, QuickClear Mechanical Thrombectomy System 8F- Straight, QuickClear Mechanical Thrombectomy System 8F- Shaped, QuickClear Mechanical Thrombectomy System 10F- Shaped, QuickClear Aspiration Pump
Volcano AtheroMed Inc. 510(k) NO: K193197(Traditional)
ATTN: Anna Gloria Stephen PHONE NO : 612 6663260
1530 O'Brien Drive, Suite A SE DECISION MADE: 20-APR-20
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vicks VNT200 No Touch Forehead Thermometer
Kaz USA, Inc., a Helen of Troy Com510(k) NO: K193213(Traditional)
ATTN: Matt J. Baun PHONE NO : 508 4907240
400 Donald Lynch Boulevard Suite 3SE DECISION MADE: 28-APR-20
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems
Philips Medical Systems Nederland 510(k) NO: K193215(Abbreviated)
ATTN: Jan Van de Kerkhof PHONE NO : 31 61 3300542
Veenpluis 4-6 SE DECISION MADE: 10-APR-20
Best NL 5684PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SensiCare PI and SensiCare PI Micro Surgical Gloves
Medline Industries, Inc. 510(k) NO: K193217(Traditional)
ATTN: Jennifer Mason PHONE NO :
Three Lakes Drive SE DECISION MADE: 06-APR-20
Northfield IL 60093 510(k) STATEMENT
DEVICE: Innovision Audio
Innovere Medical Inc. 510(k) NO: K193218(Traditional)
ATTN: Lynsie Thomason PHONE NO : 1 888 2620408
6-250 Shields Court SE DECISION MADE: 07-APR-20
Markham CA L3R 9W7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Irrigation Tubing with CO2 or Air
KeyMed (Medical and Industrial Equ510(k) NO: K193250(Traditional)
ATTN: Andy Hollingsworth PHONE NO : 44 1702 616333
KeyMed House, Stock Road SE DECISION MADE: 06-APR-20
Southend-on-Sea GB SS2 5QH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nerve and Muscle Stimulator
Shenzhen XFT Medical Limited 510(k) NO: K193275(Traditional)
ATTN: Cindy Peng PHONE NO : 86 755298 88818
Room 203, Building 1, Biomedicine SE DECISION MADE: 11-APR-20
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNA Premier
GE Healthcare (GE Medical Systems,510(k) NO: K193282(Traditional)
ATTN: Glen Sabin PHONE NO : 262 5216848
3200 N Grandview Blvd. SE DECISION MADE: 10-APR-20
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIMI-Triage CXR PTX
RADLogics, Inc. 510(k) NO: K193300(Traditional)
ATTN: Moshe Becker PHONE NO : 408 9058054
24 Westland Avenue, #28 SE DECISION MADE: 08-APR-20
Boston MA 02115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DynaClip Bone Staple
MedShape, Inc. 510(k) NO: K193305(Traditional)
ATTN: Jack Griffis PHONE NO : 678 2353311
1575 Northside Drive NW, Suite 440SE DECISION MADE: 23-APR-20
Atlanta GA 30318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NovaCross CTO Microcatheter
Nitiloop Ltd. 510(k) NO: K193322(Traditional)
ATTN: Amir Pansky PHONE NO : 972 54 6710630
1st Tidar Street SE DECISION MADE: 02-APR-20
Pardes Hanna IL 3701000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTIS Icono
Siemens Medical Solutions USA, Inc510(k) NO: K193326(Traditional)
ATTN: Patricia D. Jones PHONE NO : 610 4486474
40 Liberty Boulevard 65-1A SE DECISION MADE: 16-APR-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PreXion3D Explorer EX
PreXion Corporation 510(k) NO: K193329(Traditional)
ATTN: Hiroaki Takahashi PHONE NO : 81 3529 77551
1-14-1, Kanda Suda-cho SE DECISION MADE: 09-APR-20
Chiyoda-ku JP 101-0041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)
VitalConnect, Inc. 510(k) NO: K193343(Traditional)
ATTN: Cynthia Merrell PHONE NO : 1 408 9634600
224 Airport Parkway, Suite 300 SE DECISION MADE: 20-APR-20
San Jose CA 95110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vapocoolshot Mist
Vapocoolshot, Inc. 510(k) NO: K193349(Traditional)
ATTN: Jacob Leibovici PHONE NO : 561 4270420
1155 Main Street, Suite 105 SE DECISION MADE: 14-APR-20
Jupiter FL 33458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leadtek Fingertip Pulse Oximeter
Leadtek Research Inc. 510(k) NO: K193350(Traditional)
ATTN: K. S. Lu PHONE NO : 886 2 82265800
18F, No.166, Jian-Yi Rd., Zhonghe SE DECISION MADE: 27-APR-20
New Taipei City TW 23511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NinesAI
Nines, Inc. 510(k) NO: K193351(Traditional)
ATTN: Russell Stewart PHONE NO : 650 9246159
329 Alma St. SE DECISION MADE: 21-APR-20
Palo Alto CA 94301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dermapose Refresh
Puregraft LLC 510(k) NO: K193363(Traditional)
ATTN: Olivia Kim PHONE NO : 858 3864140
420 Stevens Avenue, Suite 220 SE DECISION MADE: 14-APR-20
Solana Beach CA 92075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xelis Dental 2.0
Infinitt Healthcare Co.,Ltd. 510(k) NO: K193369(Traditional)
ATTN: Sang Wook Cho PHONE NO : 82 2 21941631
12F Daerung Post Tower III, 27 DigSE DECISION MADE: 14-APR-20
Seoul KR 08378 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Comprehensive® Reverse Shoulder
Biomet Inc. 510(k) NO: K193373(Traditional)
ATTN: Kari Hovorka PHONE NO : 877 6520830 204
56 East Bell Drive, PO Box 587 SE DECISION MADE: 15-APR-20
Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GlassLok Kits, GlassLok Powder, GlassLok Liquid
Reliance Orthodontic Products Inc.510(k) NO: K193388(Traditional)
ATTN: Paula Wendland PHONE NO : 630 7734009
1540 West Thorndale Ave. SE DECISION MADE: 27-APR-20
Itasca IL 60143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CS Model+
Trophy 510(k) NO: K193390(Traditional)
ATTN: Marie-Pierre Labat-Camy PHONE NO : 33 164 808500
4 Rue F. Pelloutier SE DECISION MADE: 02-APR-20
Croissy-Beaubourg FR 77435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Humeral Cup Stability & Humeral Cup 135/145o Stability
FX Shoulder USA, Inc. 510(k) NO: K193394(Traditional)
ATTN: Kathy Trier PHONE NO : 800 2800775
13465 Midway Road, Suite 101 SE DECISION MADE: 29-APR-20
Dallas TX 75244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Panther Stereotactic
Prowess Inc. 510(k) NO: K193459(Traditional)
ATTN: Rachel Scarano PHONE NO : 925 3560360
1844 Clayton Road SE DECISION MADE: 27-APR-20
Concord CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ND:YAG Laser
Beijing Superlaser Technology Co.,510(k) NO: K193464(Traditional)
ATTN: Shi Shuang PHONE NO : 86 10812 84899806
No. 2 Zhongfu Street, E & T IndustSE DECISION MADE: 13-APR-20
Beijing CN 100076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Origin™ Anterior Cervical Plate System
Orthopaedic & Spine Development 510(k) NO: K193494(Traditional)
ATTN: Nicolas Palillon PHONE NO : 33 043274 0110
Chemin De Fontanille BP11211 SE DECISION MADE: 06-APR-20
Avignon Cedex 9 FR 84911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArthrexVIP Web Portal
Arthrex Inc. 510(k) NO: K193523(Special)
ATTN: Heli F Chambi Infantas PHONE NO : 1 239 5984302 73187
1370 Creekside Blvd SE DECISION MADE: 30-APR-20
Naples FL 34108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Monarch Platform
Auris Health, Inc. 510(k) NO: K193534(Traditional)
ATTN: Anna Libman PHONE NO : 408 2043370
150 Shoreline Drive SE DECISION MADE: 15-APR-20
Redwood City CA 94065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGMA High Performance (HP) Partial Knee System
DePuy Ireland UC 510(k) NO: K193549(Traditional)
ATTN: Erin Combs PHONE NO : 574 3727211
Loughbeg SE DECISION MADE: 16-APR-20
Ringaskiddy IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch
Weihai Xingtai Packaging Products 510(k) NO: K193561(Special)
ATTN: Miao Qifen PHONE NO : 86 0631 5674466
Sunjiatan Industrial Zone, YangtinSE DECISION MADE: 15-APR-20
Weihai CN 264200 510(k) STATEMENT
DEVICE: Go2Wire Guide Wire
Merit Medical System, Inc. 510(k) NO: K193571(Traditional)
ATTN: Mark Mullaney PHONE NO : 353 91 703700 3501
Parkmore Business Park West SE DECISION MADE: 08-APR-20
Galway IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro
Molnlycke Health Care US LLC. 510(k) NO: K193573(Traditional)
ATTN: Calen Souther PHONE NO : 770 5954222
5550 Peachtree Parkway, Suite 500 SE DECISION MADE: 10-APR-20
Norcross GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left
OrthoSensor, Inc. 510(k) NO: K193580(Traditional)
ATTN: Deborah Johnson PHONE NO : 954 5777770
1855 Griffin Road Suite A-310 SE DECISION MADE: 01-APR-20
Dania Beach FL 33004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DD Contrast
Dental Direkt GmbH 510(k) NO: K193588(Traditional)
ATTN: Uwe Greitens PHONE NO : 490 5225 863190
Industriezentrum 106-108 SE DECISION MADE: 16-APR-20
Spenge DE 32139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARC 400
BOWA-electronics GmbH & Co. KG 510(k) NO: K193591(Traditional)
ATTN: Wolf-Ruediger Fritz PHONE NO : 49 7072 60020
Heinrich-Hertz-Strasse. 4-10 SE DECISION MADE: 02-APR-20
Gomaringen DE 72810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants
JJGC Industria e Comercio de Mater510(k) NO: K193592(Special)
ATTN: Mariana Soares Hartmann PHONE NO : 55 41 21694058
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 28-APR-20
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine Reef TH System
SeaSpine Orthopedics Corporation 510(k) NO: K193636(Traditional)
ATTN: Aly Alvarez PHONE NO : 760 2165622
5770 Armada Drive SE DECISION MADE: 24-APR-20
Carlsbad CA 98008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearCalc
Radformation, Inc. 510(k) NO: K193640(Traditional)
ATTN: Kurt Sysock PHONE NO : 844 7233675
335 Madison Avenue, 16th floor SE DECISION MADE: 09-APR-20
New York NY 10017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BlueStar Rx
WellDoc, Inc 510(k) NO: K193654(Traditional)
ATTN: Sabyasachi Roy PHONE NO : 443 6923100
10221 Wincopin Circle, Suite 150 SE DECISION MADE: 07-APR-20
Columbia MD 21044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K200001(Traditional)
ATTN: Shi Jufang PHONE NO : 86 755 81886293
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 09-APR-20
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar
MicroPort Orthopedics Inc. 510(k) NO: K200007(Traditional)
ATTN: Allen Mamaril PHONE NO : 901 8674551
5677 Airline Road SE DECISION MADE: 25-APR-20
Arlington TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FilmArray BCID2 Control Panel M416
Maine Molecular Quality Controls, 510(k) NO: K200010(Traditional)
ATTN: Joan Gordon PHONE NO : 207 8851072
23 Mill Brook Road SE DECISION MADE: 02-APR-20
Saco ME 04072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)
Hartalega NGC Sdn. Bhd. 510(k) NO: K200019(Traditional)
ATTN: Kuan Mun Leong PHONE NO : 603 6277 1733
Kawasan Perindustrian Tanjung SE DECISION MADE: 06-APR-20
Sepang MY 43900 510(k) STATEMENT
DEVICE: FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System
LiverMoreTech Inc. 510(k) NO: K200022(Traditional)
ATTN: Jae Hong Kim PHONE NO : 1 214 2570113
801 North Jupiter Rd, Suite 200 SE DECISION MADE: 03-APR-20
Plano TX 75074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
Gold Standard Diagnostics 510(k) NO: K200023(Traditional)
ATTN: Napoleon Monce PHONE NO : 530 7598000
2851 Spafford St. SE DECISION MADE: 06-APR-20
Davis CA 95618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uMR 570
Shanghai United Imaging Healthcare510(k) NO: K200024(Traditional)
ATTN: Xin GAO PHONE NO : 86 021 67076888 5386
NO. 2258 Chengbei Road, SE DECISION MADE: 20-APR-20
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
Gold Standard Diagnostics 510(k) NO: K200025(Traditional)
ATTN: Napoleon Monce PHONE NO : 530 7598000
2851 Spafford St. SE DECISION MADE: 06-APR-20
Davis CA 95618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SkinStylus SteriLock MicroSystem
Esthetic Education LLC 510(k) NO: K200044(Traditional)
ATTN: Marc C. Sanchez PHONE NO : 202 7654491
7950 E. Acoma Drive Suite 100 SE DECISION MADE: 10-APR-20
Scottsdale AZ 85260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System
Orthofix Inc. 510(k) NO: K200052(Traditional)
ATTN: Natalia Volosen PHONE NO : 214 9372145
3451 Plano Parkway SE DECISION MADE: 09-APR-20
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)
DANNIK 510(k) NO: K200053(Traditional)
ATTN: Olga Haberlad PHONE NO : 407 7451698
941 W Morse Blvd. Suite 100 SE DECISION MADE: 21-APR-20
Winter Park FL 32789 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARx Spinal System
Life Spine Inc. 510(k) NO: K200070(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 23-APR-20
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid
Kimberly-Clark Corporation 510(k) NO: K200072(Traditional)
ATTN: Juan Marquez PHONE NO : 1 678 3526069
1400 Holcomb Bridge Road SE DECISION MADE: 10-APR-20
Roswell GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: O-arm O2 Imaging System
Medtronic Inc. 510(k) NO: K200074(Traditional)
ATTN: Dean Honkonen PHONE NO : 978 6986065
300 Foster St. SE DECISION MADE: 24-APR-20
Littleton MA 01460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARO Plan
3D Industrial Imaging Co., Ltd. 510(k) NO: K200078(Traditional)
ATTN: Myungsuk Park PHONE NO : 87 7087 669192
Bldg. 138, Rm. 413, Seoul NationalSE DECISION MADE: 10-APR-20
Seoul KR 08826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3MTM AttestTM Mini Auto-reader 490M
3M 510(k) NO: K200092(Traditional)
ATTN: Andrew Wingen PHONE NO : 651 7339209
2510 Conway Ave, Bldg 275-5W-06 SE DECISION MADE: 15-APR-20
St. Paul MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: s-Clean SQ-SL Implant System Mini
Dentis Co., Ltd. 510(k) NO: K200099(Traditional)
ATTN: Gyu Ri Kim PHONE NO : 82 5358 93541
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 13-APR-20
Daegu KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WOLF Thrombectomy V System
DeVoro Medical, Inc. 510(k) NO: K200101(Traditional)
ATTN: Michael P. Wallace PHONE NO : 925 7849985
48389 Fremont Blvd Ste 114 SE DECISION MADE: 27-APR-20
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer Hip Joint Replacement
Zimmer GmbH 510(k) NO: K200112(Traditional)
ATTN: Thomas Lincoln PHONE NO : 41 58 8548257
Sulzer Allee 6 SE DECISION MADE: 10-APR-20
Winterthur CH 8404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser Therapy Device
Shanghai Apolo Medical Technology 510(k) NO: K200118(Traditional)
ATTN: Felix Li PHONE NO : 86 138 49190618
4F, Building A, No.388, Yindu RoadSE DECISION MADE: 17-APR-20
Shanghai CN 200231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOGIQ E10s
GE Medical Systems Ultrasound and 510(k) NO: K200119(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
LLC 9900 Innovation Drive SE DECISION MADE: 01-APR-20
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Route 92 Medical 088 Access System, 110 cm
Route 92 Medical Inc. 510(k) NO: K200121(Traditional)
ATTN: Kathy Tansey PHONE NO : 408 3916536
1700 S. El Camino Real, Suite 206 SE DECISION MADE: 18-APR-20
San Mateo CA 94402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOTO PFJ System
Medacta International SA 510(k) NO: K200122(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 20-APR-20
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oxi-W System
LD Technology LLC 510(k) NO: K200141(Special)
ATTN: Albert MAAREK PHONE NO : 305 3799900
100 N. Biscayne Blvd Suite 502 SE DECISION MADE: 27-APR-20
Miami FL 33132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HI-TORQUE Steelcore Bare Guide Wire
Abbott Vascular 510(k) NO: K200144(Traditional)
ATTN: Shilpa Satishchandra PHONE NO : 408 8450775
3200 Lakeside Drive SE DECISION MADE: 08-APR-20
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOGIQ E10
GE Medical Systems Ultrasound & Pr510(k) NO: K200158(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
9900 Innovation Drive SE DECISION MADE: 17-APR-20
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)
Wuhan Greentek Pty Ltd. 510(k) NO: K200162(Abbreviated)
ATTN: Yarong Liu PHONE NO : 86 27 88185488
Rm 03-2, Flr. 3, Dingye Bldg, PhasSE DECISION MADE: 21-APR-20
Wuhan CN 430074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QuikClot Control+
Z-Medica, LLC 510(k) NO: K200167(Traditional)
ATTN: Soraya King PHONE NO : 203 9806067
4 Fairfield Boulevard SE DECISION MADE: 23-APR-20
Wallingford CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dermapose Access
Puregraft LLC 510(k) NO: K200168(Traditional)
ATTN: Olivia Kim PHONE NO : 858 3864140
420 Stevens Avenue, Suite 220 SE DECISION MADE: 22-APR-20
Solana Beach CA 92075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Comfort Rubber Gloves Industries S510(k) NO: K200181(Traditional)
ATTN: Ng Kok Howe PHONE NO : 605 8472777
Lot 821, Jalan Matang SE DECISION MADE: 15-APR-20
Matang MY 34750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYLFIRM X
Viol Co., Ltd. 510(k) NO: K200185(Traditional)
ATTN: Chai Kyoung Woo PHONE NO : 82 3180 177893
C-808, 809 Bundang Technopark C, 7SE DECISION MADE: 22-APR-20
Seongnam-si KR 13510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DSI Dental Implant System
DSI Dental Solutions Ltd 510(k) NO: K200188(Traditional)
ATTN: Shlomi Krasner PHONE NO : 972 200 3265
59 haAvoda St Light Industrial ZonSE DECISION MADE: 01-APR-20
Ashdod IL 7706300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Centaur CA 125II
Siemens Healthcare Diagnostics, In510(k) NO: K200199(Traditional)
ATTN: Fatima Pacheco PHONE NO : 914 3743770
511 Benedict Ave. SE DECISION MADE: 06-APR-20
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation 510(k) NO: K200204(Traditional)
ATTN: Rachel Gilbert PHONE NO :
200 Prospect Street SE DECISION MADE: 06-APR-20
Waltham MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Agape Warming Personal Lubricant
CC Wellness LLC 510(k) NO: K200208(Traditional)
ATTN: Marlent Perez PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 27-APR-20
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Centaur CEA Assay
Siemens Healthcare Disgnostics Inc510(k) NO: K200215(Traditional)
ATTN: Mey Lyn Vasquez PHONE NO : 914 5242458
511 Benedict Ave. SE DECISION MADE: 13-APR-20
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ControlRad Sterile Cover
ControlRad, Inc 510(k) NO: K200238(Traditional)
ATTN: Chris Fair PHONE NO : 800 5225148
275 Scientific Drive NW #1100 SE DECISION MADE: 26-APR-20
Norcross GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Turbett Instrument Pod
Turbett Surgical Inc. 510(k) NO: K200240(Traditional)
ATTN: Rob Turbett PHONE NO : 585 7550133
125 Tech Park Drive SE DECISION MADE: 30-APR-20
Rochester NY 14625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System
Medos International Sàrl 510(k) NO: K200245(Traditional)
ATTN: Rhoda Maddonni PHONE NO : 215 7937022
Chemin-Blanc 38 SE DECISION MADE: 24-APR-20
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System
ShenZhen Mindray Bio-Medical Elect510(k) NO: K200251(Traditional)
ATTN: Shi Jufang PHONE NO : 0086 755 81886293
Mindray Building, Keji 12th Road SSE DECISION MADE: 02-APR-20
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
Optina Diagnostics 510(k) NO: K200254(Traditional)
ATTN: Jean-Philippe Sylvestre PHONE NO :
7405 Route Transcanadienne, Suite SE DECISION MADE: 27-APR-20
Montreal CA H4T 1Z2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
Boston Scientific Corporation 510(k) NO: K200257(Traditional)
ATTN: Catherine Sanford PHONE NO : 508 6834498
100 Boston Scientific Way SE DECISION MADE: 17-APR-20
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Centro Vena Acute Central Line (7 French Dual Lumen)
Bard Access Systems, Inc. (Bard ha510(k) NO: K200266(Special)
ATTN: Breanna Casados PHONE NO : 801 5225909
605 North 5600 West SE DECISION MADE: 07-APR-20
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orfit Aerial Couchtop
Orfit Industries NV 510(k) NO: K200282(Traditional)
ATTN: Eddy Marivoet PHONE NO : 32 03 3262026
9A, Vosveld SE DECISION MADE: 08-APR-20
Wijnegem BE 2110 510(k) STATEMENT
DEVICE: VivAer Stylus
Aerin Medical Inc 510(k) NO: K200300(Special)
ATTN: Matthew M Hull PHONE NO : 737 2144035
232 E Caribbean Dr. SE DECISION MADE: 13-APR-20
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MTS Lefamulin 0.016- 256 µg/mL
Liofilchem s. r. 1. 510(k) NO: K200308(Traditional)
ATTN: Fabio Brocco PHONE NO : 39 085 8930745
Via Scozia zona ind.le SE DECISION MADE: 06-APR-20
Roseto degli Abruzzi IT 64026 510(k) STATEMENT
DEVICE: Tryptik Ti
Spineart 510(k) NO: K200312(Traditional)
ATTN: Frank Pennesi PHONE NO : 41 22 5701200
3 Chemin du pre Fleuri SE DECISION MADE: 06-APR-20
Plan Les Ouates CH 1228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
DeRoyal Industries, Inc. 510(k) NO: K200319(Traditional)
ATTN: Sarah Bennett PHONE NO : 865 3626112
200 DeBusk Lane SE DECISION MADE: 02-APR-20
Powell TN 37849 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Glove (Aqua Green)
Riverstone Resources SDN BHD 510(k) NO: K200326(Traditional)
ATTN: Suresh Kumar PHONE NO : 603 602 83033
Lot 55, No 13 Jalan Jasmin 2 KawasSE DECISION MADE: 09-APR-20
Bukit Beruntung MY 48300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Evry
Synaptive Medical Inc. 510(k) NO: K200327(Third Party - Traditional)
ATTN: Maham Ansari PHONE NO : 647 2433122
555 Richmond St West, Suite 800 SE DECISION MADE: 29-APR-20
Toronto CA M5V 3B1 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ProLift Lateral Fixated
Life Spine Inc. 510(k) NO: K200338(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 17-APR-20
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HS40 Diagnostic Ultrasound System
Samsung Medison Co., LTD 510(k) NO: K200339(Traditional)
ATTN: Scully Kim PHONE NO : 82 22 1941312
3366, Hanseo-ro, Nam-myeon, SE DECISION MADE: 07-APR-20
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Akros Scruture Anchor LisFranc Repair Kit
Akros Medical 510(k) NO: K200361(Traditional)
ATTN: Charles Horrell PHONE NO : 248 2595535
3503 Pleasant Green Rd SE DECISION MADE: 06-APR-20
Durham NC 27705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector
GA Health Company Limited 510(k) NO: K200388(Third Party - Traditional)
ATTN: Cindy Ye PHONE NO : 852 28 339010
Unit 18, 21/F, Metropole Square, 2SE DECISION MADE: 14-APR-20
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Single Use Biopsy Forceps FB-456D
Olympus Medical Systems Corp. 510(k) NO: K200397(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 24-APR-20
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation 510(k) NO: K200403(Traditional)
ATTN: Rachel Gilbert PHONE NO :
200 Prospect Street SE DECISION MADE: 14-APR-20
Waltham MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K200411(Traditional)
ATTN: Shi Jufang PHONE NO : 86 755 81886293
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 08-APR-20
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biomonitor III, Biomonitor IIIm
BIOTRONIK, Inc. 510(k) NO: K200444(Traditional)
ATTN: Jon Brumbaugh PHONE NO : 888 3450374
6024 Jean Road SE DECISION MADE: 23-APR-20
Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flex Body Speeder
Quality Electrodynamics, LLC 510(k) NO: K200477(Traditional)
ATTN: Eric Yeh PHONE NO : 440 4842940
6655 Beta Drive Suite 100 SE DECISION MADE: 08-APR-20
Mayfield Village OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-STAT CG4+ Cartridge with the i-STAT 1 System
Abbott point of Care, Inc. 510(k) NO: K200492(Traditional)
ATTN: Susan Tibedo PHONE NO : 609 4549360
400 College Road East SE DECISION MADE: 09-APR-20
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Molekule Air Pro RX
Molekule, Inc. 510(k) NO: K200500(Traditional)
ATTN: Frank Bianco PHONE NO : 925 4047724
1301 Folsom St. SE DECISION MADE: 15-APR-20
San Francisco CA 94103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Standard Trocar
Standard Bariatrics 510(k) NO: K200517(Traditional)
ATTN: Alison Sathe PHONE NO : 513 3047971
4362 Glendale Milford Rd. SE DECISION MADE: 09-APR-20
Cincinnati OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CarboClear® II Pedicle Screw System
CarboFix Orthopedics Ltd. 510(k) NO: K200519(Traditional)
ATTN: Hila Wachsler-Avrahami PHONE NO : 972 9951 1511
11 Ha'hoshlim St. SE DECISION MADE: 30-APR-20
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biolign® Roto-Loc Cervical Plate System
Elite Surgical Supplies (PTY) LTD 510(k) NO: K200523(Traditional)
ATTN: Thanos Spirakis PHONE NO : 27 12 3860012
54 De Havilland Cresent, PersequorSE DECISION MADE: 30-APR-20
Pretoria ZA 0020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO
Siemens Medical Solutions USA, Inc510(k) NO: K200524(Special)
ATTN: Tabitha Estes PHONE NO : 865 8044553
810 Innovation Drive SE DECISION MADE: 01-APR-20
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: binx io CT/NG Assay and binx io CT/NG System
binx health Inc 510(k) NO: K200533(Traditional)
ATTN: Sarah Kalil PHONE NO : 646 8478573
77 North Washington Street, 5th FlSE DECISION MADE: 27-APR-20
Boston MA 02114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl
Sri Trang Gloves (Thailand) Public510(k) NO: K200539(Abbreviated)
ATTN: Jarinya Jirojkul PHONE NO : 66 74 344677
10 SOi 10 Phetkasem Road SE DECISION MADE: 09-APR-20
Hatyai TH 90110 510(k) STATEMENT
DEVICE: Hive™ Stand-alone Anterior Lumbar Interbody System
HD LifeSciences LLC 510(k) NO: K200541(Traditional)
ATTN: John Sullivan PHONE NO : 603 2344321
12 Gill St Suite 4500 SE DECISION MADE: 28-APR-20
Woburn MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Traxcess 14 SELECT Guidewire
MicroVention Inc. 510(k) NO: K200547(Special)
ATTN: Ganesh Balachandar PHONE NO : 714 2478000
35 Enterprise SE DECISION MADE: 16-APR-20
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOS Lumbar Interbody System
Cutting Edge Spine, LLC 510(k) NO: K200552(Special)
ATTN: Kyle Kuntz PHONE NO : 704 2430892
101 Waxhaw Professional Park, SuitSE DECISION MADE: 02-APR-20
Waxhaw NC 28173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CarpX
PAVmed, Inc. 510(k) NO: K200559(Traditional)
ATTN: Lishan Aklog PHONE NO : 212 9494319
SE DECISION MADE: 20-APR-20
New York NY 10165 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aria System
Inova Labs 510(k) NO: K200564(Third Party - Traditional)
ATTN: Reuben Lawson PHONE NO : 619 3763032
7581 Convoy Court SE DECISION MADE: 03-APR-20
San Diego CA 92111 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ADAPT Tissue
Admedus Regen Pty Ltd 510(k) NO: K200566(Special)
ATTN: Kiran Bhirangi PHONE NO : 651 9002151
26 Harris Road SE DECISION MADE: 03-APR-20
Malaga AU 6080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearMask Transparent Surgical Face Mask
ClearMask, LLC 510(k) NO: K200576(Abbreviated)
ATTN: Aaron Hsu PHONE NO : 433 7929763
900 E. Fayette St., PO Box 22493 SE DECISION MADE: 06-APR-20
Baltimore MD 21203 510(k) STATEMENT
DEVICE: RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector
STERIS Corporation 510(k) NO: K200577(Special)
ATTN: Jennifer Nalepka PHONE NO : 440 3927458
5960 Heisley Road SE DECISION MADE: 03-APR-20
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Hartalega NGC SDN. BHD. 510(k) NO: K200581(Traditional)
ATTN: Kuan Mun Leong PHONE NO : 603 62771733
Kawasan Perindustrian Tanjung SE DECISION MADE: 25-APR-20
Sepang MY 43900 510(k) STATEMENT
DEVICE: Acuson SC2000 Diagnostic Ultrasound System
Siemens Medical Solutions, USA, In510(k) NO: K200585(Traditional)
ATTN: Christine Dunbar PHONE NO : 925 3742045
685 East Middlefield Road SE DECISION MADE: 22-APR-20
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)
bioMerieux, Inc 510(k) NO: K200590(Traditional)
ATTN: Cherece L. Jones PHONE NO : 314 7318684
595 Anglum Rd. SE DECISION MADE: 28-APR-20
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Capnostream 35 Portable Respiratory Monitor
Oridion Medical 1987 Ltd. 510(k) NO: K200594(Traditional)
ATTN: Lital David PHONE NO : 972 25899290
7 Hamarpe St. SE DECISION MADE: 27-APR-20
Jerusalem IL 9777407 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voyant Maryland Fusion Device
Applied Medical Resources Corp. 510(k) NO: K200598(Special)
ATTN: Blake Stacy PHONE NO : 949 7138163
22872 Avenida Empresa SE DECISION MADE: 08-APR-20
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sentinel
C-Rad Positioning AB 510(k) NO: K200600(Special)
ATTN: Thomas Matzen PHONE NO : 46 18666930
Bredgränd 18 SE DECISION MADE: 20-APR-20
Uppsala SE 75320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eclipse Treatment Planning System v16.0
Varian Medical Systems, Inc. 510(k) NO: K200608(Special)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
911 Hansen Way SE DECISION MADE: 03-APR-20
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tritanium® X TL Expandable Curved Posterior Lumbar Cage
Stryker Corporation 510(k) NO: K200613(Special)
ATTN: Jamie Wilson PHONE NO : 832 4986935
2 Pearl Court SE DECISION MADE: 15-APR-20
Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Focus 43C detector, TRIMAX 43C detector
iRay Technology Taicang Ltd. 510(k) NO: K200622(Special)
ATTN: Meng Li PHONE NO : 86 0512 53690872
No. 33 Xinggang Rd., Taicang Port SE DECISION MADE: 01-APR-20
Taicang CN 215434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Percutaneous Introducer
Epimed International Inc. 510(k) NO: K200624(Third Party - Traditional)
ATTN: Preston Frasier PHONE NO : 972 3739090
13958 Diplomat Drive SE DECISION MADE: 27-APR-20
Farmers Branch TX 75234 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: I-View Gold and Imagen Gold Dental Sensors
Trident s.r.l 510(k) NO: K200625(Traditional)
ATTN: Giorgio Rizzo PHONE NO : 39 0302 732485
Via Artigiani 4 SE DECISION MADE: 15-APR-20
Castenedolo IT 25014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
Medtronic, Inc. 510(k) NO: K200630(Special)
ATTN: Jen Correa PHONE NO : 949 2975494
5290 California Ave SE DECISION MADE: 09-APR-20
Irvine CA 92617 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TCAT TKA Instrument Tray Set
THINK Surgical, Inc. 510(k) NO: K200632(Special)
ATTN: George J. Prendergast PHONE NO : 510 2492323
47201 Lakeview Blvd SE DECISION MADE: 08-APR-20
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
Arrow International Inc. 510(k) NO: K200634(Special)
ATTN: Apurva N. Gokhale PHONE NO : 978 2505100
16 Elizabeth Drive SE DECISION MADE: 09-APR-20
Chelmsford MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAP-iX Suction Irrigation
Sejong Medical Co., Ltd. 510(k) NO: K200638(Special)
ATTN: Yoojung Choi PHONE NO :
11, Sinchon 2-ro SE DECISION MADE: 03-APR-20
Paju-si KR 10880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OrthAlign Plus System
OrthAlign, Inc. 510(k) NO: K200642(Special)
ATTN: Karyl Haskell PHONE NO : 949 7152424
120 Columbia, Suite 500 SE DECISION MADE: 10-APR-20
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON Freestyle Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K200644(Special)
ATTN: Shruti Arora PHONE NO : 425 3756890
685 East Middlefield Road SE DECISION MADE: 10-APR-20
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERASENSE for Stryker Triathlon
OrthoSensor, Inc. 510(k) NO: K200665(Special)
ATTN: Deborah Escobar Johnson PHONE NO : 954 5777770
1855 Griffin Road Suite A-310 SE DECISION MADE: 12-APR-20
Dania Beach FL 33004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Xia 3 Power Adaptor
Stryker Spine 510(k) NO: K200666(Special)
ATTN: Megan Callanan PHONE NO : 201 7498000
2 Pearl Court SE DECISION MADE: 23-APR-20
Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DR-ID 1200SDK System
FUJIFILM Corporation 510(k) NO: K200668(Special)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 10-APR-20
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EON Portable RO Water Purification System
Mar Cor Purification, Inc. 510(k) NO: K200670(Special)
ATTN: Mark Arnold PHONE NO : 844 3485636 243
14550 28th Avenue North SE DECISION MADE: 16-APR-20
Minneapolis MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: hyperion X5, NewTom GO, X-RADiUS COMPACT
CEFLA S.C. 510(k) NO: K200688(Traditional)
ATTN: Lorenzo Bortolotti PHONE NO : 39 0542653441
Via Selice Provinciale 23/A SE DECISION MADE: 09-APR-20
Imola IT 40026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIREBIRD SI Fusion System
Orthofix Inc. 510(k) NO: K200696(Special)
ATTN: Jacki Koch PHONE NO : 214 9372100
3451 Plano Parkway SE DECISION MADE: 02-APR-20
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JiveX
Visus Health IT GmbH 510(k) NO: K200703(Traditional)
ATTN: Axel Schreiber PHONE NO : 49 234 93693337
Gesundheitscampus-Sued 15-17 SE DECISION MADE: 14-APR-20
Bochum DE 44801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nurochek System
Cryptych Pty Ltd 510(k) NO: K200705(Third Party - Traditional)
ATTN: Angela Roche PHONE NO : 61 02 99595820
Level 15, Suite 1502, 275 Alfred SSE DECISION MADE: 23-APR-20
North Sydney AU 2060 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ACUSON Sequoia Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K200707(Third Party - Traditional)
ATTN: Sulgue Choi PHONE NO : 425 2819898
22010 South East 51st Street SE DECISION MADE: 15-APR-20
Issaquah WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Kyocera Bipolar Hip System
Kyocera Medical Technologies, Inc.510(k) NO: K200709(Special)
ATTN: Anthony DeBenedictis PHONE NO : 909 5572360
1200 California St Suite 210 SE DECISION MADE: 17-APR-20
Redlands CA 92374 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rumble Tuff Electric Breast Pump
A Cute Baby, Inc. 510(k) NO: K200712(Special)
ATTN: Matthew Kho PHONE NO : 808 6098168
865 N 1430 W SE DECISION MADE: 17-APR-20
Orem UT 84057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EchoNavigator
Philips Medical Systems Nederland 510(k) NO: K200713(Special)
ATTN: Ioana Ulea PHONE NO : 31 618 345875
Veenpluis 6 SE DECISION MADE: 09-APR-20
Best NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcuityPDR
Radmedix LLC 510(k) NO: K200726(Traditional)
ATTN: Gabriel Issa PHONE NO : 844 7236334
2510 Lance Dr. SE DECISION MADE: 13-APR-20
Dayton OH 45409 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HydroCision SpineJet System
HydroCision, Inc. 510(k) NO: K200729(Special)
ATTN: Mark J Lewis PHONE NO : 978 2891333
267 Boston Rd, Suite 28 SE DECISION MADE: 16-APR-20
North Billerica MA 01862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Opticross 35 15 MHz Peripheral Imaging Catheter
Boston Scientific Corporation 510(k) NO: K200733(Special)
ATTN: Jennifer L. Foley PHONE NO : 763 9558049
3 Scimed Place SE DECISION MADE: 17-APR-20
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Instylla Microcatheter
Instylla, Inc. 510(k) NO: K200744(Special)
ATTN: Jennifer Greer PHONE NO : 585 2602882
204 2nd Avenue SE DECISION MADE: 21-APR-20
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lariat, Hot/Cold Snare
United States Endoscopy Group, Inc510(k) NO: K200745(Special)
ATTN: Carroll Martin PHONE NO : 440 3586259
5976 Heisley Road SE DECISION MADE: 21-APR-20
Mentor OH 44060 510(k) STATEMENT
DEVICE: DB-Orthopedics
Dimensional Bioceramics, LLC 510(k) NO: K200752(Traditional)
ATTN: Duran N. Yetkinler PHONE NO : 408 7576603
2161 Delaware Ave., Suite A SE DECISION MADE: 22-APR-20
Santa Cruz CA 95060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Caption Guidance
Caption Health 510(k) NO: K200755(Traditional)
ATTN: Sam Surette PHONE NO : 571 3356532
2000 Sierra Point Pkwy SE DECISION MADE: 16-APR-20
Brisbane CA 94005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoLink Cfx Plating System
In2Bones USA, LLC 510(k) NO: K200762(Traditional)
ATTN: Christine Scifert PHONE NO : 901 8318053
6000 Poplar Ave, Suite 115 SE DECISION MADE: 23-APR-20
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Indigo Aspiration System Lightning Aspiration Tubing
Penumbra, Inc. 510(k) NO: K200771(Special)
ATTN: Micaela Victoria PHONE NO : 510 9952082
One Penumbra Place SE DECISION MADE: 22-APR-20
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eko CORE
Eko Devices, Inc. 510(k) NO: K200776(Traditional)
ATTN: Arezou Azar PHONE NO : 650 8040285
1212 Broadway, Suite 100 SE DECISION MADE: 06-APR-20
Oakland CA 94612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BSD3543W
Bontech Co. Ltd 510(k) NO: K200787(Special)
ATTN: Ki Chan Ahn PHONE NO : 82 70 86804100
Digital Empire D-Bldg #1201, DeogySE DECISION MADE: 23-APR-20
Suwon-si KR 443-702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
IRRAS USA Inc. 510(k) NO: K200807(Special)
ATTN: Niloufa Insanally PHONE NO : 858 2203761
11975 El Camino Real SE DECISION MADE: 29-APR-20
San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Affixus(R) Natural Nail(R) System Humeral Nail
Zimmer GmbH 510(k) NO: K200814(Special)
ATTN: Annemie Rehor Kausch PHONE NO : 41 58 8548261
Sulzerallee 8 SE DECISION MADE: 28-APR-20
Winterthur CH 8404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices
SpineEX, Inc. 510(k) NO: K200816(Special)
ATTN: Andrew Rogers PHONE NO : 510 5736165
4046 Clipper Court SE DECISION MADE: 30-APR-20
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks
Smith&Nephew, Inc. 510(k) NO: K200826(Special)
ATTN: Brad Sheals PHONE NO : 901 3996897
7135 Goodlett Farms Parkway SE DECISION MADE: 24-APR-20
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Mexpo International Inc. 510(k) NO: K200847(Traditional)
ATTN: Tim Thai PHONE NO : 510 4896800
2828 Faber Street SE DECISION MADE: 23-APR-20
Union City CA 94587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tiger® Occipital-Cervical-Thoracic Spinal Fixation System
CoreLink, LLC 510(k) NO: K200863(Special)
ATTN: Steve Mounts PHONE NO : 888 3497808
2072 Fenton Logistics Blvd. SE DECISION MADE: 28-APR-20
St. Louis MO 63206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Implantswiss Dental Implant System and Implantswiss Dental Abutment System
Novodent SA 510(k) NO: K200867(Special)
ATTN: Cem Kocer PHONE NO : 41 0 245242828
Y-PARC Technopole Avenue des ScienSE DECISION MADE: 28-APR-20
Yverdons-les-Bains CH CH1400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SI-Restore Sacroiliac Joint Fixation System
Biofusion Medical 510(k) NO: K200868(Special)
ATTN: Rylan Reed PHONE NO : 1 866 4890602
2101 E St Elmo Rd, Building 1, SuiSE DECISION MADE: 17-APR-20
Austin TX 74744 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AS-10
Canon, Inc. 510(k) NO: K200887(Special)
ATTN: Akira Hirai PHONE NO : 81 3 37582111
9-1 Imaikami-Cho, Nakahara-Ku SE DECISION MADE: 15-APR-20
Kawasaki JP 211-8501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solstice CCI
Life Spine Inc. 510(k) NO: K200896(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 28-APR-20
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClickClean
Medeon Biodesign, Inc. 510(k) NO: K200902(Special)
ATTN: Tsung-Yu Hsieh PHONE NO : 868 22881 6686 130
7F, 116, HouGang St., SE DECISION MADE: 30-APR-20
Taipei TW 11170 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 263
TOTAL WITH SUMMARIES 245
TOTAL WITH STATEMENTS 18
