510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD July 2023
DEVICE: AXINON® LDL-p Test System
numares AG 510(k) NO: K210801(Traditional)
ATTN: Stefanie Dukorn PHONE NO : 49 941 28094922
Am BioPark 9 SE DECISION MADE: 19-JUL-23
Regensburg DE 93053 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter
Shenzhen brav electronic technolog510(k) NO: K211143(Traditional)
ATTN: Kai Wang PHONE NO : 086 18 682273850
R4-5/F, Block 11, Tongfuyu IndustrSE DECISION MADE: 17-JUL-23
Shenzhen CN 518060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Alaris System with Guardrails Suite MX v12.1.2
CareFusion 303 Inc. 510(k) NO: K211218(Traditional)
ATTN: Laurie Cartwright PHONE NO : 858 9874203
10020 Pacific Mesa Blvd. SE DECISION MADE: 21-JUL-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Teleflex Rusch SoftSimplastic Foley Catheters
Teleflex Medical, Inc. 510(k) NO: K212077(Traditional)
ATTN: Kelley Breheim PHONE NO : 612 5001344
3015 Carrington Mill Blvd SE DECISION MADE: 27-JUL-23
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Panther 5
Origin Medical Devices 510(k) NO: K213098(Traditional)
ATTN: Brent Chamblee PHONE NO : 512 7712609
23 Corporate Plaza SE DECISION MADE: 20-JUL-23
Newport Beach CA 92660 510(k) STATEMENT
DEVICE: FMT Reusable Temperature Probes
Metko Medikal ve Ttbbi Cihazlar D1510(k) NO: K213100(Traditional)
ATTN: Burcu Firat PHONE NO : 90 312 3871246
Ivedik O.S.B. Agac Isleri Sanayi SSE DECISION MADE: 18-JUL-23
Yenimahalle - Ankara TR 06378 510(k) STATEMENT
DEVICE: DEKA ACE Pump System
DEKA Research and Development 510(k) NO: K213536(Traditional)
ATTN: Paul Smolenski PHONE NO : 603 2060371
340 Commercial Street SE DECISION MADE: 25-JUL-23
Manchester NH 03101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes
Becton Dickinson and Company 510(k) NO: K213953(Traditional)
ATTN: Angela Mariani PHONE NO : 860 5084352
1 Becton Drive SE DECISION MADE: 17-JUL-23
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-STAT PTplus Cartridge with the i-STAT 1 System
Abbott Laboratories 510(k) NO: K220282(Traditional)
ATTN: Melissa Tristani PHONE NO : 609 4549360
400 College Road East SE DECISION MADE: 14-JUL-23
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Play&Joy InvisiLube Lubricant Capsule
InnoveMed Bio-tech Co., Ltd. 510(k) NO: K220646(Traditional)
ATTN: David Chien PHONE NO : 886 2552 9398
6F, No. 184, Sec. 2, Chongqing N. SE DECISION MADE: 10-JUL-23
Taipei City TW 103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HS Fiber Cerclage
Riverpoint Medical, LLC 510(k) NO: K220765(Traditional)
ATTN: Edwin Anderson PHONE NO : 503 5178001
815 NE 25th Ave SE DECISION MADE: 26-JUL-23
Portland OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer
Beckman Coulter Laboratory Systems510(k) NO: K220977(Traditional)
ATTN: Tracy Jin PHONE NO : 86 512 68955129
No. 181 West Su Hong Road, Suzhou SE DECISION MADE: 20-JUL-23
Suzhou CN 215021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tissue Approximation System (TAS)
TAS Medical, Inc. 510(k) NO: K220980(Traditional)
ATTN: Michael Tozzi PHONE NO :
1100 Industrial Road SE DECISION MADE: 05-JUL-23
San Carlos CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARGUS PB-3000
SCHILLER AG 510(k) NO: K221056(Traditional)
ATTN: Iru Rothfuchs PHONE NO : 41 41 7664242
Altgasse 68 SE DECISION MADE: 06-JUL-23
Baar CH 6341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LungTrainer (MD2 & MD3)
Lung Trainers, LLC 510(k) NO: K221058(Traditional)
ATTN: Frank Acosta PHONE NO : 1 786 2864744
8000 NW 7 ST, STE 202 SE DECISION MADE: 05-JUL-23
Miami FL 33126 510(k) STATEMENT
DEVICE: TRUST
Rgorithm Korea 510(k) NO: K221107(Traditional)
ATTN: Jun Ho Song PHONE NO : 82 10 45203143
A-1502, 606 Seobusaet-gil, GuemcheSE DECISION MADE: 18-JUL-23
Geumcheon-gu KR 08504 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Play and Joy Water-Based Lubricant
InnoveMed Bio-tech Co., Ltd. 510(k) NO: K221137(Traditional)
ATTN: Linda Li PHONE NO : 886 22552 939825
6F, No.184, Sec. 2, Chongqing N. RSE DECISION MADE: 11-JUL-23
Taipei CN 10357 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Edge Upper Cervical System
Spinal Simplicity LLC 510(k) NO: K221307(Traditional)
ATTN: Adam Rogers PHONE NO : 913 4514414
6363 College Boulevard Suite 320 SE DECISION MADE: 10-JUL-23
Overland Park KS 66211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Alaris™ Pump Epidural Infusion Set
CareFusion 510(k) NO: K221319(Traditional)
ATTN: Paulina Davis PHONE NO : 714 2565344
10020 Pacific Mesa Blvd SE DECISION MADE: 21-JUL-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Alaris™ Pump Infusion Sets
CareFusion 510(k) NO: K221327(Traditional)
ATTN: Roya Borazjani PHONE NO : 801 2310002
10020 Pacific Mesa Blvd SE DECISION MADE: 21-JUL-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Emit® II Plus Buprenorphine Assay
Siemens Healthcare Diagnostics, In510(k) NO: K221605(Traditional)
ATTN: Julie Warren PHONE NO : 302 4155107
500 GBC Dr. P.O. Box 6101, MailstoSE DECISION MADE: 25-JUL-23
Newark DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARinse CTS Specimen Collection and Transport System
Aardvark Medical, Inc. 510(k) NO: K221664(Traditional)
ATTN: Steven Bacich PHONE NO : 650 2185934
55 Bolinas Ave SE DECISION MADE: 03-JUL-23
Ross CA 94957 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bonafix TiBase
Zentek Medical LLC 510(k) NO: K221673(Traditional)
ATTN: Michael Vinnik PHONE NO : 732 2840545
200 Craig Road Ste. 107 SE DECISION MADE: 14-JUL-23
Manalapan NJ 07726-8735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Sutures with or without Needle
Huaian Seamen Medical Technology C510(k) NO: K221767(Traditional)
ATTN: Xinjie Zhang PHONE NO : 0517 8384406
No. 6, Wangyuan Pioneer Park (QunlSE DECISION MADE: 31-JUL-23
Huaian CN 223008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HydroMARK Plus Breast Biopsy Site Marker
Devicor Medical Products, Inc. 510(k) NO: K221961(Traditional)
ATTN: Katy Austin PHONE NO : 513 8649047
300 E-Business Way, Fifth Floor SE DECISION MADE: 13-JUL-23
Cincinnati OH 45241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Integral Titanium Cervical Interbody
Nvision Biomedical Technologies, I510(k) NO: K222015(Traditional)
ATTN: Diana Langham PHONE NO : 210 5453713
4590 Lockhill Selma SE DECISION MADE: 05-JUL-23
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Implant System - Zirconia Implant System
JJGC Industria e Comercio de Mater510(k) NO: K222026(Traditional)
ATTN: Barbara Uzae PHONE NO : 55 41 21694000
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 14-JUL-23
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
Siemens Healthcare Diagnostics Inc510(k) NO: K222116(Traditional)
ATTN: Joy Anoop PHONE NO : 516 2323307
511 Benedict Avenue SE DECISION MADE: 13-JUL-23
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpinMedix Absorbable Fibrous Membrane
CelestRay Biotech Company, LLC 510(k) NO: K222220(Traditional)
ATTN: Charles C Han PHONE NO : 202 8085668
PO Box 341754 SE DECISION MADE: 06-JUL-23
Bethesda MD 20827-1754 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-LYTE® Integrated Multisensor (IMT Na K Cl)
Siemens Healthcare Diagnostics Inc510(k) NO: K222438(Traditional)
ATTN: Joy Anoop PHONE NO : 516___ 2323307
511 Benedict Avenue SE DECISION MADE: 25-JUL-23
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PatCom Distal Chip Endoscope
H&A Mui Enterprises Inc. 510(k) NO: K222587(Traditional)
ATTN: Tammy Mui PHONE NO : 905 8905525
145 Traders Blvd. E., Unit #34 SE DECISION MADE: 28-JUL-23
Mississauga CA L4Z 3L3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-View 3D Pan/X-View 2D Pan
Trident s.r.l 510(k) NO: K222666(Traditional)
ATTN: Giorgio Rizzo PHONE NO : 39 030 2732485
Via Artigiani 4 SE DECISION MADE: 10-JUL-23
Castenedolo IT 25014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fibroid Mapping Reviewer Application (FMRA)
Nesa Medtech Private Limited 510(k) NO: K222683(Traditional)
ATTN: Sreekar Kothamachu PHONE NO : 91 99001 66988
15, 33rd Main 7th Block Bhavani CoSE DECISION MADE: 17-JUL-23
Bengaluru IN 560085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IH Implant System
Sewon Medix Inc. 510(k) NO: K222707(Traditional)
ATTN: Jinsoo Lee PHONE NO : 82 51 3031713
#29, Sa-sang-ro, 375beon-gil, Sa-sSE DECISION MADE: 07-JUL-23
Sa-sang-gu KR 46700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HJY VisualNext Endoscopic Vision System
HJY Smart Medical Device Co., Ltd.510(k) NO: K222735(Traditional)
ATTN: John Jiannyuh Chen PHONE NO : 886 933 869246
12F., No. 415, Sec. 4, Xinyi Dist.SE DECISION MADE: 28-JUL-23
Taipei City TW 11051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Axial3D Insight
Axial Medical Printing Limited 510(k) NO: K222745(Traditional)
ATTN: Jenna McGarry PHONE NO : 447 749 147256
17A Ormeau Avenue SE DECISION MADE: 03-JUL-23
Belfast GB BT2 8HD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlowStar Touch Digital Mixer Flowmeter
Baldus Sedation GmbH & Co. KG 510(k) NO: K222794(Traditional)
ATTN: Lisa Baldus PHONE NO : 0049 261 963892666
In der Langfuhr 32 SE DECISION MADE: 28-JUL-23
Bendorf DE 56170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC
Lotuxs Medtech (Suzhou) Co., Ltd. 510(k) NO: K222862(Traditional)
ATTN: Na Wu PHONE NO : 86 512 62880553
Room301,303,304, Building6, NorthwSE DECISION MADE: 30-JUL-23
Suzhou Industrial Park, Suzhou CN510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CarboClear Cervical Cage System, CarboClear Cervical VBR System
CarboFix Orthpedics Ltd. 510(k) NO: K222874(Traditional)
ATTN: Yael Rubin PHONE NO : 972 9 9511511
11 Ha'Hoshlim Street SE DECISION MADE: 26-JUL-23
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrocardiograph: SE-1200 Pro and SE-1201 Pro
Edan Instruments, Inc. 510(k) NO: K222902(Traditional)
ATTN: Milin Wu PHONE NO : 86 755 84513592
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 28-JUL-23
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oxygen concentrator
Zhengzhou Olive Electronic Technol510(k) NO: K222920(Traditional)
ATTN: Yunping Qu PHONE NO : 86 371 86097307
5th Floor, Block D, Building 18, HSE DECISION MADE: 20-JUL-23
Zhenghou CN 450001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hypodermic Syringes & Needle
Lifelong Meditech Private Limited 510(k) NO: K222925(Traditional)
ATTN: Mr. Hamendra Nath SrivastavaPHONE NO : 91 981 0661915
Plot No.18, Sector-5, IMT Manesar SE DECISION MADE: 18-JUL-23
Gurgaon IN 122050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B
Shenzhen AOJ Medical Technology Co510(k) NO: K222994(Traditional)
ATTN: Jack Wang PHONE NO : 86 755 27786026
Room 301 & 4F, Blk A, Building A, SE DECISION MADE: 26-JUL-23
Shenzhen CN 518126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer, Model: IR8807
Shen Zhen Rong Feng Technology Co.510(k) NO: K223037(Traditional)
ATTN: Hong Xiao Lan PHONE NO : 86 137 15151187
3/F R Building ShaSi Industrial PaSE DECISION MADE: 21-JUL-23
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RenaNav Ureteroscope System
CenterPoint Systems LLC 510(k) NO: K223097(Traditional)
ATTN: Marybeth Gamber PHONE NO : 774 2495250
3338 Parkway Blvd SE DECISION MADE: 31-JUL-23
West Valley City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)
Brainlab AG 510(k) NO: K223106(Traditional)
ATTN: Marc Bergenthal PHONE NO : 49 899 915680
Olof-Palme-Str. 9 SE DECISION MADE: 14-JUL-23
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XR90 (XR90-SYS)
MediView XR, Inc. 510(k) NO: K223125(Traditional)
ATTN: Adam Cargill PHONE NO : 661 9179775___
10000 Cedar Ave STE# GCIC 2-153 SE DECISION MADE: 13-JUL-23
Cleveland OH 44106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nu-beca Transcutaneous Electrical Nerve Stimulation
Nu-Beca & Maxcellent Co. 510(k) NO: K223151(Traditional)
ATTN: David Tsai PHONE NO : 886 2 28363617 6000
3F-1, No. 45, Dexing W. Rd SE DECISION MADE: 19-JUL-23
Taipei TW 111046 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Proxeo ULTRA (PB-510, PB-520 and PB-530)
W&H Dentalwerk Buermoss GmbH 510(k) NO: K223173(Traditional)
ATTN: Weidler Gerhard PHONE NO : 0043 6274 62369339
Ignaz-Glaser-Strasse 53 SE DECISION MADE: 14-JUL-23
Buermoos AT 5111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Firefighter™ NC Pro PTCA Balloon Catheter
Shanghai MicroPort Medical (Group)510(k) NO: K223189(Traditional)
ATTN: Xia Tian PHONE NO : 86 021 38954600__
1601 ZhangDong Road, ZJ Hi-Tech PaSE DECISION MADE: 21-JUL-23
Shanghai CN 201203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tandem Mobi Insulin Pump with Interoperable Technology
Tandem Diabetes Care, Inc. 510(k) NO: K223213(Traditional)
ATTN: Ashley Schneider PHONE NO : 858 3666900
11075 Roselle Street SE DECISION MADE: 10-JUL-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas
Exactech, Inc 510(k) NO: K223252(Traditional)
ATTN: Elizabeth Howell PHONE NO : 352 3771140
2320 NW 66th Ct SE DECISION MADE: 17-JUL-23
Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Open Rib
Canon Medical Informatics, Inc. 510(k) NO: K223261(Traditional)
ATTN: Vincent Swenson PHONE NO : 952 4879548
5850 Opus Parkway, Suite 300 SE DECISION MADE: 13-JUL-23
Minnetonka MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
Brainlab AG 510(k) NO: K223288(Traditional)
ATTN: Esther Moreno Garcia PHONE NO : 49 89 9915680
Olof-Palme-Str. 9 SE DECISION MADE: 21-JUL-23
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)
SentiAR, Inc. 510(k) NO: K223290(Traditional)
ATTN: Alexander Schreiner PHONE NO : 952 2215458
212 N Kingshighway Blvd., Suite 11SE DECISION MADE: 14-JUL-23
St. Louis MO 63108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System
SpineCraft, LLC 510(k) NO: K223301(Traditional)
ATTN: Ami Akallal-Asaad PHONE NO : 1 630 9207300
777 Oakmont Lane, Suite 200 SE DECISION MADE: 20-JUL-23
Westmont IL 60559 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System
Conformis Inc. 510(k) NO: K223316(Traditional)
ATTN: Mary Kruitwagen PHONE NO : 781 3459038
600 Technology Park Drive, 4th FloSE DECISION MADE: 21-JUL-23
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alkaline Phosphatase2
Abbott Ireland Diagnostics Divisio510(k) NO: K223317(Traditional)
ATTN: Julian Braz PHONE NO : 224 3309230
Lisnarnuck SE DECISION MADE: 21-JUL-23
Longford IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Argus Cognitive ReVISION Software
Argus Cognitive, Inc. 510(k) NO: K223322(Traditional)
ATTN: Attila Meretei PHONE NO : 603 4002440
Dartmouth Regional Technical CenteSE DECISION MADE: 24-JUL-23
Lebanon NH 03766 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bone Chamber Implant
MegaGen Implant Co., Ltd. 510(k) NO: K223339(Traditional)
ATTN: Eun Mi Park PHONE NO : 82 53 2223859
45, Secheon-ro, 7-gil SE DECISION MADE: 18-JUL-23
Daegu KR 42921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UltraSight AI Guidance
UltraSight Inc. 510(k) NO: K223347(Traditional)
ATTN: Davidi Vortman PHONE NO : 972 52 8544654
1 Hamada St. SE DECISION MADE: 24-JUL-23
Rehovot IL 7670301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AeviceMD
Aevice Health Pte. Ltd. 510(k) NO: K223382(Traditional)
ATTN: Adrian Ang PHONE NO : 65 9 0058825
18 Howard Road, #06-11 Novelty BizSE DECISION MADE: 07-JUL-23
Singapore SG 369585 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invia® Integrated Dressing
Medela AG 510(k) NO: K223388(Traditional)
ATTN: Judith Bernardo PHONE NO : 41 41 5621656
Lättichstrasse 4b SE DECISION MADE: 07-JUL-23
Baar CH 6340 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spine Auto Views
GE Medical Systems SCS 510(k) NO: K223424(Traditional)
ATTN: Yonghui Han PHONE NO : 1 262 2251914
283, rue de la Miniere SE DECISION MADE: 13-JUL-23
Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHELON Synergy MRI system
FUJIFILM Healthcare Corporation 510(k) NO: K223426(Traditional)
ATTN: Randy Vader PHONE NO : 360 356 6821
2-1, Shintoyofuta SE DECISION MADE: 13-JUL-23
Kashiwa-Shi JP 277-0804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bladder Scanner Model: BVT02
Xuzhou Kaixin Electronic Instrumen510(k) NO: K223448(Traditional)
ATTN: Chunmei Xu PHONE NO : 0086 516 87792599
Kaixin Mansion, C-01, Economic DevSE DECISION MADE: 07-JUL-23
Xuzhou CN 221004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ME-APDS™; MAGENTIQ-COLO™
Magentiq Eye LTD 510(k) NO: K223473(Traditional)
ATTN: Dror Zur PHONE NO : 972 772 018838
6 Ben Gurion Blvd. SE DECISION MADE: 25-JUL-23
Haifa IL 3541416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IGAR System (1001.A)
Insight Medbotics Inc. 510(k) NO: K223484(Traditional)
ATTN: Paul Chipperton PHONE NO : 647 2918545
39 Charlton Avenue East SE DECISION MADE: 20-JUL-23
Hamilton CA L8N 1Y3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Three Way Stop Cock
M/s Romsons International 510(k) NO: K223499(Traditional)
ATTN: Kishore Narian Khanna PHONE NO : 91 562 6620000
Unit-II, 9, Noida Special EconomicSE DECISION MADE: 21-JUL-23
Noida IN 201305 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CNS-2101 Central Monitor
Nihon Kohden Corporation 510(k) NO: K223567(Traditional)
ATTN: Sandra Gadeyne PHONE NO : 949 3563401
1-31-4 Nishiochiai, Shinjuku-Ku SE DECISION MADE: 31-JUL-23
Tokyo JP 161-8560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T3 Platform software
Etiometry, Inc. 510(k) NO: K223578(Traditional)
ATTN: Timothy Hanson PHONE NO : 857 3669333 2020
280 Summer St., 4th Floor SE DECISION MADE: 07-JUL-23
Boston MA 02210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cobas® SARS-CoV-2 & Influenza A/B for use on the cobas® Liat System
Roche Molecular Systems, Inc. 510(k) NO: K223591(Dual Track)
ATTN: Aradhana Karthikeyan PHONE NO : 925 3537713
4300 Hacienda Drive SE DECISION MADE: 27-JUL-23
Pleasanton CA 94588-2722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Comprehensive Segmental Revision System(SRS)
Biomet Orthopedics 510(k) NO: K223631(Traditional)
ATTN: Alexandria Irwin PHONE NO : 1 574 3710213
56 East Bell Drive SE DECISION MADE: 12-JUL-23
Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys proBNP II, Elecsys proBNP II STAT
Roche Diagnostics 510(k) NO: K223637(Traditional)
ATTN: Jane Phillips PHONE NO : 317 5213338
9115 Hague Road SE DECISION MADE: 21-JUL-23
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MESI mTablet ECG Diagnostic System, MESI mTablet ECG
MESI, Development of Medical Devic510(k) NO: K223670(Traditional)
ATTN: Jakob Susteric PHONE NO : 386 1 6203487
Leskoskova cesta 11 A SE DECISION MADE: 28-JUL-23
Ljubljana SI 1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnteraLoc Flow
Vonco Products 510(k) NO: K223683(Traditional)
ATTN: Christie Marr PHONE NO : 262 2987203
10826 250th Avenue SE DECISION MADE: 10-JUL-23
Trevor WI 53179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: i-STAT CG8+ cartridge with the i-STAT 1 System
Abbott Point of Care Inc. 510(k) NO: K223710(Traditional)
ATTN: Jacquelyn Gesumaria PHONE NO : 609 4549384
400 College Road East SE DECISION MADE: 28-JUL-23
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOZI TPS
Manteia Technologies Co., Ltd. 510(k) NO: K223724(Traditional)
ATTN: Chao Fang PHONE NO : 86 0592 6100813
1903-1904, B Tower, Zijin Plaza, NSE DECISION MADE: 10-JUL-23
Xiamen CN 361001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Micro Rx
IMDS Operations B.V. 510(k) NO: K223728(Traditional)
ATTN: Edwin Schulting PHONE NO : 31 651 152743
Ceintuurbaan Noord 150 SE DECISION MADE: 13-JUL-23
Roden NL 9301NZ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Whitsundays Mask System
ResMed Pty Ltd (Registration Numbe510(k) NO: K223747(Traditional)
ATTN: Shu-Ying Huang PHONE NO : 65 657 27105
1 Elizabeth Macarthur Drive SE DECISION MADE: 06-JUL-23
Bella Vista AU 2153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl
Central Medicare Sdn. Bhd. 510(k) NO: K223752(Traditional)
ATTN: Chua Kah Ying PHONE NO : 605 6290000
PT 2609-2620, Batu 8, Jalan ChangkSE DECISION MADE: 24-JUL-23
Teluk Intan MY 36000 510(k) STATEMENT
DEVICE: NextAR™ Spine Platform
Medacta International S.A. 510(k) NO: K223769(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 21-JUL-23
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lumos 3DX
3Dio 510(k) NO: K223780(Traditional)
ATTN: Douglas Hansen PHONE NO : 801 7962951
1119 South 1680 West SE DECISION MADE: 06-JUL-23
Orem UT 84058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantisal™ II Oral Fluid Collection Device
Immunalysis Corporation 510(k) NO: K223781(Traditional)
ATTN: Shubhajit Mitra PHONE NO : 508 3304796
829 Towne Center Drive SE DECISION MADE: 28-JUL-23
Pomona CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TalWire
Embrace Medical Ltd. 510(k) NO: K223791(Traditional)
ATTN: Anat Kaufman PHONE NO : 972 523 265853
21(B) Habarzel Street SE DECISION MADE: 14-JUL-23
Tel-Aviv IL 6971029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTICALE® Triangular Fixation System
Silony Medical GmbH 510(k) NO: K223806(Traditional)
ATTN: Ralf Klabunde PHONE NO :
Leinfelder StraBe 60 SE DECISION MADE: 06-JUL-23
Leinfelden-Echterdingen DE 70771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zavation Navigation Instrument System
Zavation Medical Products, LLC 510(k) NO: K223808(Traditional)
ATTN: Katie Motley PHONE NO : 601 9191119
3670 Flowood Drive SE DECISION MADE: 12-JUL-23
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccuCheck
Manteia Technologies Co., Ltd. 510(k) NO: K223834(Traditional)
ATTN: Yingkai Lin PHONE NO : 86 0592 6100813
1903, B Tower, Zijin Plaza, No.181SE DECISION MADE: 20-JUL-23
Xiamen CN 361001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wearable Breast Pump (Model S18)
Shenzhen TPH Technology Co., Ltd. 510(k) NO: K223886(Traditional)
ATTN: Peter Chen PHONE NO : 86 0755 82703212
5th floor,Lianchuang 2nd technologSE DECISION MADE: 14-JUL-23
Shenzhen CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric Scooter (Model: M2020)
Guangdong Prestige Technology Co.,510(k) NO: K230001(Traditional)
ATTN: Zhang Zhao PHONE NO :
No. 8, Road.1, 3rd Ind. District, SE DECISION MADE: 05-JUL-23
Dongguan CN 523950 510(k) STATEMENT
DEVICE: Disposable Hemoclip
Yangzhou Fartley Medical Instrumen510(k) NO: K230004(Traditional)
ATTN: Tina Han PHONE NO : 0086 1505 1101225
Beizhou Road, Lidian Town, GuangliSE DECISION MADE: 31-JUL-23
Yangzhou CN 225106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cercare Medical Neurosuite
Cercare Medical A/S 510(k) NO: K230016(Traditional)
ATTN: Peter Loekke PHONE NO : 45 22 770000
Inge Lehmanns Gade 10 SE DECISION MADE: 14-JUL-23
Aarhus DK DK-8000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IVYLASER Handhold Hair Removal Machine
Ivylaser (Beijing) Technology Co.,510(k) NO: K230025(Traditional)
ATTN: Yuan Xiujuan PHONE NO : 086 010 60299801
Room 411, Building 3, No. 2 ShengfSE DECISION MADE: 03-JUL-23
Beijing CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACK 3
SWIMS America Corp 510(k) NO: K230037(Traditional)
ATTN: Matthieu Commeau PHONE NO : 917 3717388
1133 Westchester Avenue Suite N 22SE DECISION MADE: 19-JUL-23
White Plains NY 10604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uOmnispace
Shanghai United Imaging Healthcare510(k) NO: K230039(Traditional)
ATTN: Gao Xin PHONE NO : 86 21 67076888
No. 2258 Chengbei Rd., Jiading DisSE DECISION MADE: 20-JUL-23
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rapid Aneurysm Triage and Notification
iSchemaView Inc. 510(k) NO: K230074(Traditional)
ATTN: James Rosa PHONE NO : 303___ 7043374
1120 Washington Ave., Ste 200 SE DECISION MADE: 27-JUL-23
Golden CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LaserME
Neauvia North America 510(k) NO: K230077(Traditional)
ATTN: Joy Willard PHONE NO : 984 7775296
8480 Honeycutt Road SE DECISION MADE: 17-JUL-23
Raleigh NC 27615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood
Yangzhou Medline Industry Co., Ltd510(k) NO: K230080(Traditional)
ATTN: Hu Tingting PHONE NO : 86 514 87525616
No.108, Jinshan Road, Economic DevSE DECISION MADE: 07-JUL-23
Yangzhou CN 225000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: “POINT” Kinguide Agile Hybrid Navigation System
Point Robotics Medtech Inc. 510(k) NO: K230087(Traditional)
ATTN: Sandy Lin PHONE NO : 886 2 29130272 166
7F. No. 219, Sec. 3, Beixin Rd. XiSE DECISION MADE: 17-JUL-23
New Taipei City TW 231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OptimMRI
RebrAIn, SAS 510(k) NO: K230150(Traditional)
ATTN: Ram Bedi PHONE NO : 425 9858670
PTIB - Hôpital Xavier Arnozan - AvSE DECISION MADE: 21-JUL-23
Pessac FR 33600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Servo-air Lite Ventilator System
Maquet Critical Care AB 510(k) NO: K230173(Traditional)
ATTN: David Ardanius PHONE NO : 46 10 3357300
Rontgenvagen 2 SE DECISION MADE: 06-JUL-23
Solna SE SE-171 54 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Intramedullary Nails
Arthrex, Inc. 510(k) NO: K230257(Traditional)
ATTN: Stacy Valdez PHONE NO : 1 239 6435553 72010
1370 Creekside Boulevard SE DECISION MADE: 17-JUL-23
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultraflex™ Tracheobronchial Stent System
Boston Scientific Corporation 510(k) NO: K230269(Special)
ATTN: Catherine Sanford PHONE NO : 508 6834498
100 Boston Scientific Way SE DECISION MADE: 14-JUL-23
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dentis i-Clean System
Dentis Co., Ltd. 510(k) NO: K230307(Traditional)
ATTN: Gyu Ri Kim PHONE NO : 82 535 893646
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 11-JUL-23
Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
Kettenbach GmbH & Co. KG 510(k) NO: K230333(Traditional)
ATTN: Katja Simon PHONE NO : 49 277 47050
Im Heerfeld 7 SE DECISION MADE: 24-JUL-23
Eschenburg DE 35713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonio Detect
Sonio 510(k) NO: K230365(Traditional)
ATTN: Florian Akpakpa PHONE NO : 0033 6193 87145
24 Rue du Faubourg Saint Jacques SE DECISION MADE: 25-JUL-23
Paris FR FR-75014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CROSSLEAD Penetration Peripheral Guide Wire
ASAHI INTECC Co., Ltd. 510(k) NO: K230377(Special)
ATTN: Katsuhiko Fujimura PHONE NO : 81 561 561859
3-100 Akatsuki-cho SE DECISION MADE: 20-JUL-23
Seto JP 489-0071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)
DURIO PPE SDN BHD 510(k) NO: K230395(Traditional)
ATTN: Xavier Kong PHONE NO : 60 733 11385
16, Jalan Temenggong SE DECISION MADE: 17-JUL-23
Johor Bahru MY 81100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FloNavi Open Field Fluorescence Imaging System
Guangdong OptoMedic Technologies, 510(k) NO: K230407(Traditional)
ATTN: Alice Lau PHONE NO : 86 075 786702920
Suite 503, Building A, Golden VallSE DECISION MADE: 17-JUL-23
Foshan CN 528200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUSA Clarity Ultrasonic Surgical Aspirator System
Integra Lifesciences Corporation 510(k) NO: K230427(Traditional)
ATTN: Alexandra Wells PHONE NO : 609 9036300
1100 Campus Rd SE DECISION MADE: 11-JUL-23
Princeton NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OnX Tough
SprintRay Inc. 510(k) NO: K230445(Traditional)
ATTN: Sara Moghtadernejad PHONE NO : 800 9148004
2705 Media Center Drive, Suite 100SE DECISION MADE: 14-JUL-23
Los Angeles CA 90065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Enamel Coating Resin
Rizhao HuGe Biomaterials Company, 510(k) NO: K230455(Traditional)
ATTN: Maggie Zheng PHONE NO : 86 633 2277268
No.2 North Zhaoyang Road, DistrictSE DECISION MADE: 25-JUL-23
Rizhao City CN 276800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIX H2 Patient Specific Instrument System
Vilex, LLC 510(k) NO: K230462(Traditional)
ATTN: Brock Johnson PHONE NO : 801 9164157
111 Moffitt Street SE DECISION MADE: 17-JUL-23
McMinnville TN 37110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Lithium Disilicate Glass-Ceramic
Fuzhou Rick Brown Biomaterials Co.510(k) NO: K230487(Traditional)
ATTN: Zhong Huang PHONE NO : 86 0591 23507151
The first and second floors of R&DSE DECISION MADE: 03-JUL-23
Fuzhou CN 350100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MyEllevate
Cynosure, LLC 510(k) NO: K230510(Traditional)
ATTN: Cynthia Aguirre PHONE NO : 480 4019884
5 Carlisle Road SE DECISION MADE: 06-JUL-23
Westford MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADx Intraoral Appliance for Snoring and Sleep Apnea
Achaemenid LLC 510(k) NO: K230532(Abbreviated)
ATTN: Rachel Miller PHONE NO : 949 2300902
2318 Main Street SE DECISION MADE: 12-JUL-23
Stratford CT 06615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient Specific Planning Solution™ 3D Bone Models
Biomet Manufacturing Corp. 510(k) NO: K230540(Traditional)
ATTN: Katherine Choi PHONE NO : 260 6022359
56 East Bell Drive SE DECISION MADE: 25-JUL-23
Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revital-Ox PAA High Level Disinfectant Chemical Indicator
STERIS Corporation 510(k) NO: K230558(Traditional)
ATTN: Gregory Land PHONE NO : 440 3927424
5976 Heisley Road SE DECISION MADE: 17-JUL-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: enspire 300 Series Automated Endoscope Reprocessor System
STERIS Corporation 510(k) NO: K230560(Traditional)
ATTN: Gregory Land PHONE NO : 440 3927424
5960 Heisley Road SE DECISION MADE: 21-JUL-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 )
Cardinal Health 510(k) NO: K230569(Abbreviated)
ATTN: Caroline Miceli PHONE NO : 312 2702013
3651 Birchwood Drive SE DECISION MADE: 03-JUL-23
Waukegan IL 60085 510(k) STATEMENT
DEVICE: IDENTIFY
Varian Medical Systems Inc. 510(k) NO: K230576(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
911 Hansen Way SE DECISION MADE: 25-JUL-23
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)
Xstrahl Ltd 510(k) NO: K230611(Traditional)
ATTN: Vineet Gupta PHONE NO : 415 3205048
Unit 2 Maybrook Industrial Estate SE DECISION MADE: 13-JUL-23
Brownhills GB WS8 7DG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZENEX Implant System_Narrow
Izenimplant Co., Ltd. 510(k) NO: K230630(Traditional)
ATTN: Kwon Mi-Kyung PHONE NO : 82 316 620657
1, 2Dong, 26-32, Suworam 4-Gil, SeSE DECISION MADE: 31-JUL-23
Pyeongtaek-Si KR 17703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anthogyr Surgical Cassettes
Anthogyr 510(k) NO: K230680(Traditional)
ATTN: Aude Goulet PHONE NO : 33 045 0580237
2237 Avenue André Lasquin SE DECISION MADE: 11-JUL-23
Sallanches FR 74700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Robotic Graft Delivery Instruments
Medtronic Sofamor Danek Inc 510(k) NO: K230716(Traditional)
ATTN: Diamond Wallace PHONE NO : 901 3963133
2600 Sofamor Danek Drive SE DECISION MADE: 18-JUL-23
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001
Light Tree Ventures Europe B.V. 510(k) NO: K230720(Traditional)
ATTN: Kim Laurens PHONE NO : 86 1351__ 03787481
Laan van Ypenburg 108, 2497 GC, ThSE DECISION MADE: 03-JUL-23
Hague NL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NB Implant System
Arum Dentistry Co., Ltd. 510(k) NO: K230725(Traditional)
ATTN: Boyeon Lim PHONE NO : 82 42 9353644
23, Gukjegwahak 11-ro, Yuseong-gu SE DECISION MADE: 01-JUL-23
Daejeon KR 34002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apyx
Escala Medical 510(k) NO: K230730(Traditional)
ATTN: Edit Goldberg PHONE NO : 972 72 2607000
17 Tchelet Street SE DECISION MADE: 25-JUL-23
Misgav IL 2017400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oscar 15 & Oscar 15i
Genoray Co., Ltd. 510(k) NO: K230787(Traditional)
ATTN: Jiyeon Lee PHONE NO : 82 31 51785770
512, 560, Dunchon-daero, Jungwon-gSE DECISION MADE: 20-JUL-23
Seongnam-si KR 13230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pathfinder Endoscope Overtube with Balloon Device
Neptune Medical, Inc. 510(k) NO: K230801(Traditional)
ATTN: Alex Tilson PHONE NO : 650 3072176
1828 El Camino Real, Suite 508 SE DECISION MADE: 28-JUL-23
Burlingame CA 94010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Complement Kit Cases
JJGC Indústria e Comércio de Mater510(k) NO: K230804(Traditional)
ATTN: Barbara Uzae PHONE NO : 55 41 21694058
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 07-JUL-23
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BlueStar and BlueStar Rx
Welldoc, Inc. 510(k) NO: K230813(Traditional)
ATTN: David Boser PHONE NO : 248 2495243
10221 Wincopin Circle, Ste #150 SE DECISION MADE: 28-JUL-23
Columbia MD 21044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AusculThing ACC
AusculThing Oy 510(k) NO: K230823(Traditional)
ATTN: Jani Virtanen PHONE NO : 35 850 3801134
Ruusutorpanpuisto 4 A 15 SE DECISION MADE: 12-JUL-23
Espoo FI 02600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets
Cardinal Health 200, LLC 510(k) NO: K230838(Traditional)
ATTN: Emily Hunter PHONE NO : 847 8876367
3651 Birchwood Drive SE DECISION MADE: 27-JUL-23
Waukegan IL 60085 510(k) STATEMENT
DEVICE: iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System
Conformis, Inc. 510(k) NO: K230846(Traditional)
ATTN: Nancy Giezen PHONE NO : 781 3459058
600 Technology Park Dr. SE DECISION MADE: 17-JUL-23
Billerica MA 01830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUATERA 700
Carl Zeiss Meditec AG 510(k) NO: K230858(Traditional)
ATTN: Hans-Joachim Miesner PHONE NO : 49 3641 220362
Goeschwitzer Strasse 51-52 SE DECISION MADE: 31-JUL-23
Jena DE 07745 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
ZEUS Scientific 510(k) NO: K230863(Traditional)
ATTN: Mark Kopnitsky PHONE NO : 908 2434904
200 Evans Way SE DECISION MADE: 13-JUL-23
Branchburg NJ 08876 510(k) STATEMENT
DEVICE: VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin
BioMerieux, Inc 510(k) NO: K230864(Traditional)
ATTN: Jared Bronson PHONE NO : 314 2018799
595 Anglum Rd. SE DECISION MADE: 05-JUL-23
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims
Central Medicare Sdn. Bhd. 510(k) NO: K230875(Traditional)
ATTN: Chua Kah Ying PHONE NO : 60 562 90000
PT 2609-2620, Batu 8, Jalan ChangkSE DECISION MADE: 20-JUL-23
Teluk Intan MY 36000 510(k) STATEMENT
DEVICE: Admira Fusion 5
VOCO GmbH 510(k) NO: K230877(Traditional)
ATTN: Katrin Fröhlich PHONE NO : 49 4721__ 7190
Anton-Flettner-Str. 1-3 SE DECISION MADE: 13-JUL-23
Cuxhaven DE 27472 510(k) STATEMENT
DEVICE: FLUOBEAM® LX Red
Fluoptics Sas 510(k) NO: K230898(Special)
ATTN: Marion Boudet PHONE NO : 33 0 485870673
44 rue des berges SE DECISION MADE: 28-JUL-23
Grenoble FR 38000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Premier HpSA Flex (619096)
Meridian Bioscience, Inc. 510(k) NO: K230901(Traditional)
ATTN: Heather Planck PHONE NO : 513 9915946
3471 River Hills Drive SE DECISION MADE: 03-JUL-23
Cincinnati OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANDI
Imeka Solutions, Inc. 510(k) NO: K230913(Traditional)
ATTN: Valerie Lacroix PHONE NO : 888 3110599
195, Belvedere Nord #201 SE DECISION MADE: 25-JUL-23
Sherbrooke CA J1H 4A7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atlan
Drägerwerk AG Co. KGaA 510(k) NO: K230931(Traditional)
ATTN: Marianne Selent PHONE NO : 49 451 8821602
Moislinger Allee 53-55 SE DECISION MADE: 23-JUL-23
Lübeck DE 23542 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANDORATE® Valve Kit
GA Health Company Limited 510(k) NO: K230932(Traditional)
ATTN: Cindy Ye PHONE NO : 852 2833 9010
Unit 18, 21/F, Metropole Square, 2SE DECISION MADE: 07-JUL-23
Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIRA® Posterior Lumbar Spacers
Camber Spine Technologies 510(k) NO: K230942(Traditional)
ATTN: Brooks McAdam PHONE NO : 484 4277060
501 Allendale Rd SE DECISION MADE: 11-JUL-23
King of Prussia PA 19406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Forma Medical Headless Compression Screw
Forma Medical, Inc. 510(k) NO: K230945(Traditional)
ATTN: James A. Gault PHONE NO : 717___ 2867687
3401 Hartzdale Drive, Suite 103B, SE DECISION MADE: 18-JUL-23
Camp Hill PA 17011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Respiratory Viral Panel for BD MAX™ System 445215; BD Respiratory Viral Panel-SCV2 for BD MAX™ System 445361
BD Integrated Diagnostic Solutions510(k) NO: K230956(Traditional)
ATTN: Kathy Barnecut PHONE NO : 1 858 2102284
Becton, Dickinson & Company 7 LoveSE DECISION MADE: 31-JUL-23
Sparks MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VYBE RF Electrosurgical System
ShenB Co Ltd 510(k) NO: K230968(Special)
ATTN: Sunny Kang PHONE NO : 82 70 49122702
ShenB Bldg 148 Seongsui-ro SE DECISION MADE: 06-JUL-23
Seoul KR 04796 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC)
Guangdong OptoMedic Technologies, 510(k) NO: K231003(Traditional)
ATTN: Weijuan Guo PHONE NO : 0 757 86702920
Suite 503, Building A, Golden VallSE DECISION MADE: 06-JUL-23
Foshan CN 528200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
Kimberly-Clark Corporation 510(k) NO: K231021(Traditional)
ATTN: Kimberly Tempas PHONE NO : 920 7214084
1400 Holcomb Bridge Road SE DECISION MADE: 21-JUL-23
Roswell GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FusedCO Algorithm
Edwards Lifesciences LLC 510(k) NO: K231035(Traditional)
ATTN: Omar Becerra PHONE NO : 949 2501478
One Edwards Way SE DECISION MADE: 12-JUL-23
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Global Hypoperfusion Index (GHI) Algorithm
Edwards Lifesciences, LLC 510(k) NO: K231038(Traditional)
ATTN: Michelle Ducca PHONE NO : 805 3686785
1 Edwards Way SE DECISION MADE: 26-JUL-23
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JiveX (Model Number / Release: 5.4)
VISUS Health IT GmbH 510(k) NO: K231041(Traditional)
ATTN: Axel Schreiber PHONE NO : 49 234 93693337
Gesundheitscampus-Sued 15 SE DECISION MADE: 14-JUL-23
Bochum DE 44801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R2P Navicross
Terumo Medical Corporation 510(k) NO: K231044(Traditional)
ATTN: Sandeep Chiplonkar PHONE NO : 609 4239454
950 Elkton Blvd SE DECISION MADE: 27-JUL-23
Elkton MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReddyPort Elbow
SMD Manufacturing LLC 510(k) NO: K231064(Traditional)
ATTN: Jared Spendlove PHONE NO : 801 4581959
918 S 500 W, Ste A SE DECISION MADE: 13-JUL-23
Salt Lake City UT 84101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
Esthetic Medical Inc. 510(k) NO: K231073(Traditional)
ATTN: Kristin Groop PHONE NO : 602 6195726___
7950 E. Acoma Dr., Ste. 208 SE DECISION MADE: 28-JUL-23
Scottsdale AZ 85260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcQMap High Resolution Imaging and Mapping System
Acutus Medical Inc 510(k) NO: K231091(Traditional)
ATTN: Karla Schaffner PHONE NO : 1 442 2326161
2210 Faraday Ave, Suite 100 SE DECISION MADE: 10-JUL-23
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROSA ONE Brain Application
Medtech S.A.S 510(k) NO: K231103(Traditional)
ATTN: Paul Hardy PHONE NO : 574___ 3735011
432 rue du Rajol SE DECISION MADE: 20-JUL-23
Mauguio FR 34130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.CT Lung CAD (Version VD30)
Siemens Healthcare GmbH 510(k) NO: K231157(Traditional)
ATTN: Abhineet Johri PHONE NO : 49 9191 184429
Siemensstr. 1 SE DECISION MADE: 19-JUL-23
Forchheim DE 91301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe
Becton, Dickinson and Company 510(k) NO: K231161(Traditional)
ATTN: Samhitha Mohan PHONE NO : 214 9710979
1 Becton Dr SE DECISION MADE: 21-JUL-23
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ApolloKnee
Corin USA Limited 510(k) NO: K231172(Traditional)
ATTN: Aaron Brunt PHONE NO : 44 07970 237346
12750 Citrus Park Lane SE DECISION MADE: 26-JUL-23
Tampa FL 33625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Irregular Rhythm Notification Feature (IRNF)
Apple Inc. 510(k) NO: K231173(Traditional)
ATTN: Bonnie Wu PHONE NO : 408 9740617
One Apple Park Way SE DECISION MADE: 21-JUL-23
Cupertino CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brainomix 360 Triage ICH
Brainomix Limited 510(k) NO: K231195(Traditional)
ATTN: Szrnka Zsolt PHONE NO : 0044 7949 013914
First Floor Seacourt Tower West WaSE DECISION MADE: 27-JUL-23
Oxford GB OX2 0JJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDx-Chex for BC-GP
Streck 510(k) NO: K231221(Traditional)
ATTN: Megan Hiveley PHONE NO : 402 5375208
7002 S. 109th Street SE DECISION MADE: 27-JUL-23
La Vista NE 68128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDx-Chex for BC-GN
Streck 510(k) NO: K231223(Traditional)
ATTN: Cody A. Janssen PHONE NO : 402 5375216
7002 S. 109th Street SE DECISION MADE: 27-JUL-23
La Vista NE 68128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IBS-B MIS Beveled Screw System
In2Bones USA, LLC 510(k) NO: K231236(Traditional)
ATTN: Christine Scifert PHONE NO : 901 8318053
6000 Poplar Ave, Suite 115 SE DECISION MADE: 27-JUL-23
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NanoHive Medical Lumbar Interbody System
NanoHive Medical LLC 510(k) NO: K231241(Traditional)
ATTN: Ian Helmar PHONE NO : 1 844 9435433
12 Gill Street Suite 4500 SE DECISION MADE: 12-JUL-23
Woburn MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL
PENTAX of America, Inc. 510(k) NO: K231249(Traditional)
ATTN: William Goeller PHONE NO : 201 5712300 2318
3 Paragon Drive SE DECISION MADE: 28-JUL-23
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Overture Orthopaedics Patellofemoral System
Overture Resurfacing Inc. 510(k) NO: K231253(Traditional)
ATTN: Riley Williams PHONE NO :
1617 3rd Ave, #287284 SE DECISION MADE: 07-JUL-23
New York NY 10128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Altaviz Needle Kit II
Altaviz, LLC 510(k) NO: K231261(Traditional)
ATTN: James Lescoulie PHONE NO : 310 5691105
13766 Alton Parkway, Suite 143 SE DECISION MADE: 27-JUL-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exceed™ Biplanar Expandable Interbody System
Spine Wave, Inc. 510(k) NO: K231275(Traditional)
ATTN: Ronald K. Smith PHONE NO : 203 7121846
3 Enterprise Drive SE DECISION MADE: 25-JUL-23
Shelton CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm
Ablative Solutions, Inc. 510(k) NO: K231279(Traditional)
ATTN: Kristine Canavan PHONE NO : 617 8777953
301 Edgewater Place Suite 100 SE DECISION MADE: 05-JUL-23
Wakefield MA 01880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement
Carbofix Orthopedics Ltd. 510(k) NO: K231280(Traditional)
ATTN: Yael Rubin PHONE NO : 97 299 511511
11 Ha'hoshlim St. SE DECISION MADE: 03-JUL-23
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System
Bonebridge AG 510(k) NO: K231292(Traditional)
ATTN: Michelle Gumpelmayer PHONE NO : 41 767 310732
Bahnhofstrasse 11 SE DECISION MADE: 19-JUL-23
Zug CH 6300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID
Biosense Webster Inc. 510(k) NO: K231312(Special)
ATTN: Caleb Lau PHONE NO : 949 7041584
31 Technology Drive, Suite 200 SE DECISION MADE: 10-JUL-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Therapy Mask 3100 NC/SP
Respironics Inc. 510(k) NO: K231313(Special)
ATTN: Shipra Gulati PHONE NO : 617 6507502
1001 Murry Ridge Lane SE DECISION MADE: 28-JUL-23
Murrysville PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)
Beijing ADSS Development Co., Ltd.510(k) NO: K231318(Traditional)
ATTN: Song Ying PHONE NO : 86 1305 1615111
Room 609, F6, Building 13, Yard 5 SE DECISION MADE: 07-JUL-23
Beijing CN 102600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nooance Led And Laser Helmet
Shenzhen Kaiyan Medical Equipment 510(k) NO: K231321(Traditional)
ATTN: Alain Dijkstra PHONE NO : 0755 82 129361
Building#3 and Building#5, 40th ofSE DECISION MADE: 31-JUL-23
Shenzhen CN 518103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tyber Medical Pin and Wire System (various)
Tyber Medical, LLC 510(k) NO: K231339(Traditional)
ATTN: Nicole Merlini PHONE NO : 484 2744471
83 South Commerce Way Suite 310 SE DECISION MADE: 06-JUL-23
Bethlehem PA 18017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Chondral Quant
Siemens Medical Soultions USA, Inc510(k) NO: K231351(Traditional)
ATTN: Milind Dhamankar PHONE NO : 1 610 5179484
40 Liberty Boulevard SE DECISION MADE: 13-JUL-23
Malvern PA 19335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Universal Seal (5-12 mm)
Intuitive Surgical, Inc. 510(k) NO: K231358(Traditional)
ATTN: Emily Hovick PHONE NO : 314 3598534___
1266 Kifer Road SE DECISION MADE: 05-JUL-23
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste
Orthocon, Inc. 510(k) NO: K231386(Traditional)
ATTN: Aniq Darr PHONE NO : 855 4759175
700 Fairfield Avenue - Suite 1 SE DECISION MADE: 11-JUL-23
Stamford CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endofill
Lumendo AG 510(k) NO: K231387(Traditional)
ATTN: Mark Bispinghoff PHONE NO : 41 445 896802
Chemin du Closel 5 SE DECISION MADE: 10-JUL-23
Renens CH 1020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NaviNetics Reusable Stereotactic System (NN1000)
NaviNetics Inc. 510(k) NO: K231392(Traditional)
ATTN: Danielle Jondal PHONE NO : 507 3613576
206 S Broadway STE 700 SE DECISION MADE: 14-JUL-23
Rochester MN 55904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RenaPure Endotoxin Retentive Filter
Evoqua Water Technologies LLC 510(k) NO: K231410(Traditional)
ATTN: Robert Dudek PHONE NO : 1 978 6147359
558 Clark Road SE DECISION MADE: 19-JUL-23
Tewksbury MA 01876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)
Biosense Webster, Inc. 510(k) NO: K231412(Special)
ATTN: Caleb Lau PHONE NO : 949 7041584
31 Technology Drive, Suite 200 SE DECISION MADE: 10-JUL-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mobility Scooter (Models: W3431D)
Zhejiang Innuovo Rehabilitation De510(k) NO: K231428(Traditional)
ATTN: Grace Li PHONE NO : 86 159 24234767
No.196 Industry Road, Hengdian MovSE DECISION MADE: 14-JUL-23
Dongyang CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LF900
Daesung Maref Co., Ltd 510(k) NO: K231437(Special)
ATTN: Su Hyeon So PHONE NO : 82 31 4597211
298-24, Gongdan-ro SE DECISION MADE: 19-JUL-23
Gunpo-Si KR 15809 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System
Alphatec Spine, Inc. 510(k) NO: K231438(Traditional)
ATTN: Unnati Bhuptani PHONE NO : 1 760 3566711
1950 Camino Vida Roble SE DECISION MADE: 13-JUL-23
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIX Ankle System
Jeil Medical Corporation 510(k) NO: K231441(Traditional)
ATTN: Dajung Lee PHONE NO : 82 285 03591
702,703,704,705,706,804,805,807,81SE DECISION MADE: 17-JUL-23
Seoul KR 08378 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TANDEM Hip System
Smith & Nephew, Inc. 510(k) NO: K231448(Traditional)
ATTN: Nikita Deshpande PHONE NO : 901 8258527
1450 Brooks Road SE DECISION MADE: 19-JUL-23
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Portable X-ray System Model Ray98(P)
Ningbo Runyes Medical Instrument C510(k) NO: K231449(Traditional)
ATTN: Weiqiong Fang PHONE NO : 86 574 27709922
No. 456 Tonghui Road, Jiangbei InvSE DECISION MADE: 13-JUL-23
Ningbo CN 315000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avitus® DragonWing Large Volume Autograft Delivery System
Avitus Orthopaedics, Inc. 510(k) NO: K231456(Traditional)
ATTN: Maxim Budyansky PHONE NO : 860 3727213
6 Armstrong Rd., 2nd Floor SE DECISION MADE: 17-JUL-23
Shelton CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System
K&J Consulting Corp. 510(k) NO: K231460(Traditional)
ATTN: Jeena Mathai PHONE NO : 716 4655551
2260 Glenview Dr, SE DECISION MADE: 16-JUL-23
Lansdale PA 19446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)
Suzhou Sweetrich Vehicle Industry 510(k) NO: K231472(Traditional)
ATTN: Ryan Chen PHONE NO : 86 13818 232111
No. 68 Xinfa Road, Suzhou IndustriSE DECISION MADE: 19-JUL-23
Suzhou CN 215000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Erchonia Violet ZERONA® Z6 OTC
Erchonia Corporation 510(k) NO: K231474(Traditional)
ATTN: Travis Sammons PHONE NO : 321 4731251
650 Atlantis Rd. SE DECISION MADE: 21-JUL-23
Melbourne FL 32904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bright MTA Sealer Plus
Genoss Co., Ltd. 510(k) NO: K231480(Traditional)
ATTN: Boram Choi PHONE NO : 82 70 70986352
D-factory, 56, Changnyong-daero 25SE DECISION MADE: 28-JUL-23
Suwon-si KR 16229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MySpine Unilateral Guides
Medacta International S.A. 510(k) NO: K231483(Traditional)
ATTN: Stefano Baj PHONE NO : 00 419 16966060
Strada Regina SE DECISION MADE: 21-JUL-23
Castel San Pietro CH 6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INHANCE™ Shoulder System, Sterile Single Use Instrumentation
Depuy Ireland UC 510(k) NO: K231516(Traditional)
ATTN: Yayoi Fujimaki PHONE NO : 508 8283541
Loughbeg SE DECISION MADE: 21-JUL-23
Ringaskiddy IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EsCom250
Spident Co., Ltd. 510(k) NO: K231523(Traditional)
ATTN: Eunok Choi PHONE NO : 82 10 42226153
203 & 312, Korea Industrial CompleSE DECISION MADE: 24-JUL-23
Incheon KR 405-821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bonalive Orthopedics granules
Bonalive Biomaterials, Ltd. 510(k) NO: K231528(Traditional)
ATTN: Kristoffer Sibelius PHONE NO : 35 840 0318013
Biolinja 12 SE DECISION MADE: 11-JUL-23
Turku FI 20750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dia-Cem
Diadent Group International 510(k) NO: K231552(Traditional)
ATTN: Kab Sun Lee PHONE NO : 82 43 2662315
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 28-JUL-23
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))
iSMART Developments Ltd 510(k) NO: K231555(Traditional)
ATTN: Susan D'Arcy PHONE NO : 44 788 0313315
129 Green Lanes, Boldmere, Sutton SE DECISION MADE: 27-JUL-23
Birmingham GB B73 5LT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
Hardy Diagnostics 510(k) NO: K231568(Traditional)
ATTN: Anna Klavins PHONE NO : 800 2662222 5752
1430 West McCoy Lane SE DECISION MADE: 06-JUL-23
Santa Maria CA 93455 510(k) STATEMENT
DEVICE: uMI Panorama
Shanghai United Imaging Healthcare510(k) NO: K231572(Traditional)
ATTN: Xin Gao PHONE NO : 86 21670 768885386
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 26-JUL-23
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOBILETT Impact
Siemens Medical Solutions 510(k) NO: K231577(Traditional)
ATTN: Camila Rodriguez Valentin PHONE NO : 240 8135702
40 Liberty Boulevard SE DECISION MADE: 25-JUL-23
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Tubing Lines for Hemodialysis AV06C-E
Nikkiso Co., Ltd. 510(k) NO: K231589(Traditional)
ATTN: Satoko Hina PHONE NO : 81 334 433754
20-3, Ebisu 4-Chome SE DECISION MADE: 28-JUL-23
Shibuya-Ku JP 150-6022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-Print c&b temp
VOCO GmbH 510(k) NO: K231591(Traditional)
ATTN: Sarah Schaudel PHONE NO : 49 47 217190
Anton-Flettner-Str. 1-3 SE DECISION MADE: 31-JUL-23
Cuxhaven DE 27472 510(k) STATEMENT
DEVICE: Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.
Zhuzhou Goldenhot Medical Technolo510(k) NO: K231613(Traditional)
ATTN: Liu Xianwu PHONE NO : 86 138 08497058
Room 301, Plant C-3, Phase 5, XinmSE DECISION MADE: 31-JUL-23
Zhuzhou CN 412007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3 Layer Surgical Mask (134252531)
Original Mattress Factory Inc. 510(k) NO: K231618(Traditional)
ATTN: Nathan Elseser PHONE NO : 216 3516922
4930 State Road SE DECISION MADE: 28-JUL-23
Cleveland OH 44134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed ViewFlex Xtra ICE Catheter (D087031)
Stryker Sustainability Solutions 510(k) NO: K231621(Special)
ATTN: Mia Brown PHONE NO : 480 3431855
1810 West Drake Drive SE DECISION MADE: 25-JUL-23
Tempe AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rotium Bioresorbable Wick
Nanofiber Solutions, LLC 510(k) NO: K231641(Special)
ATTN: Jason Chakroff PHONE NO : 614 5654161
5164 Blazer Parkway SE DECISION MADE: 05-JUL-23
Dublin OH 43017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter
Thrombolex, Inc. 510(k) NO: K231653(Special)
ATTN: Amy Katsikas PHONE NO : 267 8983986
75 New Britain Dr. SE DECISION MADE: 03-JUL-23
New Britain PA 18901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spine CAMP™ (1.1)
Medical Metrics, Inc. 510(k) NO: K231668(Special)
ATTN: Kirk Johnson PHONE NO : 210 2188405
2121 Sage Road Suite 300 SE DECISION MADE: 07-JUL-23
Houston TX 77056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AllTest Fentanyl Rapid Test (Urine)
Hangzhou AllTest Biotech Co., Ltd.510(k) NO: K231698(Traditional)
ATTN: Rosa Wu PHONE NO : 86 571 58120615
#550, Yinhai Street Hangzhou EconoSE DECISION MADE: 31-JUL-23
Hangzhou CN 310018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ziehm Vision RFD 3D
Ziehm Imaging GmbH 510(k) NO: K231701(Special)
ATTN: Stefan Fiedler PHONE NO : 0911 66067219
Lina-Ammon-Strasse 10 SE DECISION MADE: 10-JUL-23
Nuremberg DE 90471 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4
Radmedix LLC 510(k) NO: K231709(Traditional)
ATTN: Gabriel Issa PHONE NO : 844 7236334
2510 Lance Dr SE DECISION MADE: 12-JUL-23
Dayton OH 45409 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: microINR System
iLine Microsystems S.L. 510(k) NO: K231711(Special)
ATTN: Miren Itsaso Hormaeche PHONE NO : 34 943 005651
Paseo Mikeletegi, 69 SE DECISION MADE: 11-JUL-23
San Sebastian-Donostia ES 20009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Graftys Quickset
Graftys 510(k) NO: K231714(Special)
ATTN: Cedric Bonneau PHONE NO : 0033 443 603000
415 Rue Claude Nicolas Ledoux EiffSE DECISION MADE: 12-JUL-23
Aix en Provence FR 13854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System
NuVasive, Incorporated 510(k) NO: K231735(Special)
ATTN: Hannah Tan PHONE NO : 707 6965075
7475 Lusk Boulevard SE DECISION MADE: 11-JUL-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MemorialTM Gloves
US Glove Supply 510(k) NO: K231740(Third Party - Traditional)
ATTN: Jacomo Hakim PHONE NO : 516 4563642
300 Commerce Drive SE DECISION MADE: 04-JUL-23
Buffalo NY 14218 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Praxiject™ 0.9% NaCl
MedXL Inc. 510(k) NO: K231754(Special)
ATTN: Hina Saini PHONE NO : 1 514 6933150
285 Avenue Labrosse SE DECISION MADE: 13-JUL-23
Pointe-Claire CA H9R 1A3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ez3D-i /E3
Ewoosoft Co., Ltd 510(k) NO: K231757(Special)
ATTN: Young Seok Kim PHONE NO :
801-ho, Vatechnetworks Bldg., 13, SE DECISION MADE: 14-JUL-23
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: activL® Next Generation Instrumentation
Aesculap Implants Systems LLC 510(k) NO: K231769(Special)
ATTN: Hamza Ahmed PHONE NO : 610 737 3900
3773 Corporate Parkway SE DECISION MADE: 13-JUL-23
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlowSaver Blood Return System (80-101)
Inari Medical, Inc. 510(k) NO: K231782(Special)
ATTN: Kaitlyn Weinkauf PHONE NO : 714 6152605
6001 Oak Canyon, Suite 100 SE DECISION MADE: 14-JUL-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ecoFIX®
Science & Bio materials (S.B.M.) S510(k) NO: K231787(Special)
ATTN: Anne Cospin PHONE NO : 33 562 422101
Zi Du Monge SE DECISION MADE: 26-JUL-23
Lourdes FR 65100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The InMode System with the Morpheus8 Applicators
InMode Ltd. 510(k) NO: K231790(Special)
ATTN: Suhair Francis PHONE NO : 972 4 9097470
Tabor Building, Shaar Yokneam POB SE DECISION MADE: 20-JUL-23
Yokneam Iillit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Grreen X 12 (Model: PHT-75CHS)
Vatech Co., Ltd 510(k) NO: K231796(Special)
ATTN: Daniel Kim PHONE NO : 82 31 3799492
13, Samsung 1-Ro 2-Gil SE DECISION MADE: 19-JUL-23
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INERTIA® CONNEXX™ Modular Pedicle Screw System
Nexxt Spine LLC 510(k) NO: K231799(Special)
ATTN: Andy Elsbury PHONE NO : 317 4367801
14425 Bergen Blvd, Suite B SE DECISION MADE: 20-JUL-23
Noblesville IN 46060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUASAR Standalone ACIF System
GS Medical Co. Ltd. 510(k) NO: K231808(Special)
ATTN: Seon Yeon Kim PHONE NO : 82 43 2377397
90, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 20-JUL-23
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biograph Vision.X and Biograph Vision.X Edge
Siemens Medical Solutions USA, Inc510(k) NO: K231833(Special)
ATTN: Alaine Medio PHONE NO : 865___ 2060337
2501 N. Barrington Road SE DECISION MADE: 13-JUL-23
Hoffman Estates IL 60192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System
L & K Biomed Co., Ltd. 510(k) NO: K231839(Special)
ATTN: Katherine Kim PHONE NO : 82 10 54770325
#101, 201, 202 16-25, DongbaekjungSE DECISION MADE: 19-JUL-23
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CastleLoc-S Posterior Cervical Fixation System
L & K Biomed Co., Ltd. 510(k) NO: K231840(Special)
ATTN: Katherine Kim PHONE NO : 82 10 54770325
#101, 201, 202 16-25, DongbaekjungSE DECISION MADE: 20-JUL-23
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PathLoc SI Joint Fusion System
L & K Biomed Co., Ltd. 510(k) NO: K231841(Special)
ATTN: Katherine Kim PHONE NO : 82 2 67171938
#101, 201, 202 16-25, DongbaekjungSE DECISION MADE: 14-JUL-23
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProMIS™ Fixation System
Premia Spine Ltd. 510(k) NO: K231844(Special)
ATTN: Dorit Winitz PHONE NO : 972 54 8080130
7 Giborey Israel Street SE DECISION MADE: 07-JUL-23
Ramat Poleg, Netanya IL 4250407 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Triever20 Curve (21-201)
Inari Medical, Inc. 510(k) NO: K231848(Special)
ATTN: Anthony Lam PHONE NO : 909 8153702
6001 Oak Canyon Suite 100 SE DECISION MADE: 21-JUL-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoflipTM 300 System
Covidien LLC 510(k) NO: K231861(Special)
ATTN: Viviana Gonzalez PHONE NO : 410 9409773
3062 Bunker Hill Lane SE DECISION MADE: 21-JUL-23
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruDi® Navigation System V3 (FG-2000-00)
Acclarent, Inc. 510(k) NO: K231862(Special)
ATTN: Kamrie Sarnosky PHONE NO : 931 5515023
Suite 200, 31 Technology Drive SE DECISION MADE: 21-JUL-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101
STERIS Corporation 510(k) NO: K231878(Special)
ATTN: Carroll Martin PHONE NO : 440 3586259
5976 Heisley Rd SE DECISION MADE: 25-JUL-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGIVISIO Device
Ecential Robotics 510(k) NO: K231886(Special)
ATTN: Elodie Bouillet PHONE NO : 0033 4 58003586
Zone Mayencin II, Parc Equation - SE DECISION MADE: 27-JUL-23
Gieres FR 38610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-TAP (previously called Arthrotap)
Elcam Medical ACAL 510(k) NO: K231900(Special)
ATTN: Yaniv Menachem PHONE NO : 97 277 2568662
Kibbutz BarAm SE DECISION MADE: 25-JUL-23
Baram IL 1386000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Therm-X
Zenith Technical Innovations 510(k) NO: K231912(Special)
ATTN: Greg Binversie PHONE NO : 847 6727481
1396 St. Paul Ave. SE DECISION MADE: 27-JUL-23
Gurnee IL 60031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY SYNTHES MAXFRAME AUTOSTRUT System
Depuy Synthes 510(k) NO: K231922(Special)
ATTN: Mitchel Bartko PHONE NO : 1 908 8086541
1301 Goshen Parkway SE DECISION MADE: 26-JUL-23
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-IO Intraosseous Vascular Access System
Teleflex Medical 510(k) NO: K231924(Special)
ATTN: Rachel Rehl PHONE NO : 919 4332588
3015 Carrington Mill Blvd SE DECISION MADE: 25-JUL-23
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINIMA S System
LimaCorporate S.p.A. 510(k) NO: K231925(Special)
ATTN: Kenneth Newman PHONE NO : 682 5973381
Via Nazionale, 52 SE DECISION MADE: 11-JUL-23
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adena-Zina Spinal System
Shanghai Sanyou Medical Co, LTD 510(k) NO: K231931(Special)
ATTN: David Fan PHONE NO : 86 21 58389980
385 Huirong Road SE DECISION MADE: 28-JUL-23
Jiading District CN 201815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits
AngioDynamics, Inc. 510(k) NO: K231945(Special)
ATTN: Laura Dwyer PHONE NO : 1 508 6587813
603 Queensbury SE DECISION MADE: 20-JUL-23
Queensbury NY 12804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SI-Cure Sacroiliac Joint Fusion System
Alevio, LLC 510(k) NO: K231951(Special)
ATTN: Trey Robbins PHONE NO : 205 7835778
200 Cahaba Park Circle Suite 100 SE DECISION MADE: 28-JUL-23
Birmingham AL 35242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cleo
American Orthodontics 510(k) NO: K232011(Third Party - Traditional)
ATTN: Laura Richmond PHONE NO : 920 4575051 4237
3524 Washington Avenue SE DECISION MADE: 07-JUL-23
Sheboygan WI 53081 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Altris IMS
Altris, Inc. 510(k) NO: K232088(Third Party - Traditional)
ATTN: Andrew Kuropyatnyk PHONE NO : 1 773 3828709
125 South Clark Street, 17th FloorSE DECISION MADE: 31-JUL-23
Chicago IL 60603 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 251
TOTAL WITH SUMMARIES 239
TOTAL WITH STATEMENTS 12
