510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD February 2023
DEVICE: Insulin syringe with integrated needle DL
DLP Medical Products, Corp. 510(k) NO: K203211(Traditional)
ATTN: Luis Ernesto De La Puente PaPHONE NO : 525 5433306265
203 S. St. Mary's St., Suite 160 SE DECISION MADE: 09-FEB-23
San Antonio TX 78205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S.E.A.L. Hemostatic Wound Spray
BC3 Technologies Inc 510(k) NO: K210751(Traditional)
ATTN: Wayne L. Grube PHONE NO : 410 3426100
3701-A Southwestern Blvd SE DECISION MADE: 02-FEB-23
Baltimore MD 21229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Idylla MSI Test
Biocartis NV 510(k) NO: K211181(Traditional)
ATTN: Barbra Connell PHONE NO : 847 4203471
Generaal De Wittelaan 11 B3 SE DECISION MADE: 27-FEB-23
Mechelen BE 2800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InnoGenic Non-resorbable Membrane
Cowellmedi Co., Ltd. 510(k) NO: K211554(Traditional)
ATTN: Minjin Park PHONE NO : 82 51 3142028
48, Hakgam-daero 221beon-gil, SasaSE DECISION MADE: 24-FEB-23
Busan KR 46986 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System
Stryker Corporation 510(k) NO: K212194(Traditional)
ATTN: Bryan K. Hann PHONE NO : 1 269 3669863
Boetzinger Strasse 41 SE DECISION MADE: 16-FEB-23
Freiburg DE D-79111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D-RD-S
Radiopharmaceutical Imaging and Do510(k) NO: K212587(Traditional)
ATTN: Nadine Bonds PHONE NO : 253 4594341
1800 Gough St. SE DECISION MADE: 22-FEB-23
Baltimore MD 21231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sofjec
Hwajin Medical Co.,Ltd. 510(k) NO: K212635(Traditional)
ATTN: Jeon Sung Hun PHONE NO : 82 41 5546181
20, Seongsimwon-gil, Seongnam-myeoSE DECISION MADE: 13-FEB-23
Cheonan-si KR 31244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eminent Spine 3D Cervical Interbody Fusion System
Eminent Spine 510(k) NO: K212701(Traditional)
ATTN: Stephen Courtney PHONE NO : 214 4155243
2004 Ventura Drive, Suite #100 SE DECISION MADE: 06-FEB-23
Plano TX 75093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Curiteva Porous PEEK Cervical Interbody Fusion System
Curiteva, Inc. 510(k) NO: K213030(Traditional)
ATTN: Eric Linder PHONE NO : 256 2131057
25127 Will McComb Drive SE DECISION MADE: 13-FEB-23
Tanner AL 35671 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOND MMR Antibody Panel
Leica Biosystems Newcastle, Ltd. 510(k) NO: K213348(Traditional)
ATTN: Kristin Godfredsen PHONE NO : 760 4497078
Balliol Business Park West, BentonSE DECISION MADE: 21-FEB-23
Newcastle Upon Tyne GB NE12 8EW 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Handheld Pulse Oximeter S0010B
Shenzhen Witleaf Medical Electroni510(k) NO: K213431(Traditional)
ATTN: Wu Tao PHONE NO : 86 755 21384132
13/F-B2, Block 1, Senyang Science SE DECISION MADE: 26-FEB-23
Shenzhen CN 518132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
RAPID Biomedical GmbH 510(k) NO: K213480(Traditional)
ATTN: Marius Berthel PHONE NO : 49 93 6588260
Kettelerstr. 3-11 SE DECISION MADE: 01-FEB-23
Rimpar DE 97222 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869
Steelco S.P.A. 510(k) NO: K213545(Abbreviated)
ATTN: Veronica Basso PHONE NO : 011 39 4345772911
Via Balegante, 27 SE DECISION MADE: 02-FEB-23
Riese Pio X IT 31039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMILE
Nu Eyne Co., Ltd. 510(k) NO: K213629(Traditional)
ATTN: Dong Seong Lee PHONE NO : 82 2 69538120
#608, 28, Digital-ro 30-gil, Guro-SE DECISION MADE: 12-FEB-23
Seoul KR 08389 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTSCALPEL LS-4020
LightScalpel Inc 510(k) NO: K213669(Traditional)
ATTN: David Walters PHONE NO : 425 3681588
11818 North Creek Parkway N Suite SE DECISION MADE: 15-FEB-23
Bothell WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
GBS Commonwealth Co., Ltd. 510(k) NO: K213755(Traditional)
ATTN: Jimmy Kim PHONE NO : 82 2 69254469
C-309, Woolim Lion's Valley, 168, SE DECISION MADE: 17-FEB-23
Geumcheon-gu KR 08507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endocem MTA Premixed Regular
Maruchi 510(k) NO: K213757(Traditional)
ATTN: SungWook Jang PHONE NO : 82 33 7340330
2-208, Medical Industry Complex BlSE DECISION MADE: 14-FEB-23
Wonju-si KR 26311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Vida
Siemens Medical Solutions USA, Inc510(k) NO: K213805(Traditional)
ATTN: Karthik Pillai PHONE NO : 317 3718593
Mail Code 65-1A SE DECISION MADE: 24-FEB-23
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Gown
Bayteks Teknik Tekstil San. ve Tic510(k) NO: K213844(Traditional)
ATTN: Spero Hegbe PHONE NO : 90 530 1493463
Organize Sanaji Bolgesi 19. Nolu CSE DECISION MADE: 16-FEB-23
Merkez TR 79000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large
Smith and Nephew Medical Limited 510(k) NO: K213853(Traditional)
ATTN: Jean-Marie Steeve PHONE NO : 44 7583 04872
101 Hessle Road SE DECISION MADE: 10-FEB-23
Hull GB HU3 2BN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Everion+ System
Biofourmis Singapore Pte. Ltd 510(k) NO: K213863(Traditional)
ATTN: Milan Shah PHONE NO : 617 9478255
2 Venture Drive, Vision Exchange, SE DECISION MADE: 23-FEB-23
Singapore SG 608526 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RealNow
YIWEI Medical Technology Co., Ltd 510(k) NO: K213891(Traditional)
ATTN: Eric Ke PHONE NO : 86 0755 82333762
Room1001,MaiKelongBuilding,No.6,GaSE DECISION MADE: 24-FEB-23
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOFIRE SPOTFIRE Respiratory (R) Panel
BioFire Diagnostics 510(k) NO: K213954(Dual Track)
ATTN: Kevin Bourzac PHONE NO : 801 7366354 1358
515 Colorow Drive SE DECISION MADE: 03-FEB-23
Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantia IgE
Biokit, S.A. 510(k) NO: K214068(Special)
ATTN: Angels Roma PHONE NO : 34 938 609000
Av. Can Montcau, 7 SE DECISION MADE: 21-FEB-23
Llica d'Amunt ES 08186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Milli Vaginal Dilator
Materna Medical 510(k) NO: K220035(Traditional)
ATTN: Kelly Ashfield PHONE NO : 866 4336933
2495 Hospital Drive, Suite 300 SE DECISION MADE: 27-FEB-23
Mountain View CA 94040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Geonic Nasal Aspirator, Geonic Nasal Cleaner
Geon Corporation 510(k) NO: K220126(Traditional)
ATTN: Henry Chen PHONE NO : 886 488 52476
No. 12, Gung Ye Road SE DECISION MADE: 02-FEB-23
Hsi Hu, Chang Hwa Hsien TW 514 510(k) STATEMENT
DEVICE: Painless IPL System - KDT750
Shanghai Omni Laser Skinology Co.,510(k) NO: K220214(Traditional)
ATTN: Avril Ouyang PHONE NO : 86 21 54847192
Floor 3, Building 3, NO.227, MingqSE DECISION MADE: 18-FEB-23
Shanghai CN 201612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer TET-351
Truly Instrument Limited 510(k) NO: K220276(Traditional)
ATTN: LiuJin Ting PHONE NO : 86 0660 3363561
Truly Industrial Area, Shan Wei CiSE DECISION MADE: 17-FEB-23
Shanwei CN 516600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Manta Ray TDF Spacer
SeaSpine Orthopedics Corporation 510(k) NO: K220296(Traditional)
ATTN: Kavita Chandrashekar PHONE NO : 858 4051276
5770 Armada Drive SE DECISION MADE: 03-FEB-23
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GaiaBone Bioabsorbable Bone Graft
Corliber (Shenzhen) Medical Device510(k) NO: K220337(Traditional)
ATTN: Sun Yang PHONE NO : 86 755 23007976
#103, BLK 6, 14 Zhongxing Rd, KengSE DECISION MADE: 03-FEB-23
Shenzhen City CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEJONG Surgical Gown Soft
Sejong Healthcare Co., Ltd. 510(k) NO: K220435(Traditional)
ATTN: Bong Sung Lee PHONE NO : 82 31 9421700
1502-1, Tongil-ro, Paju-eup, Paju-SE DECISION MADE: 10-FEB-23
Paju –si KR 10836 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATTIVA
Italian Engineering srl 510(k) NO: K220505(Traditional)
ATTN: Elisabetta Tonelli PHONE NO : 39 051 6013915
Via dell'Elettricista, 38 SE DECISION MADE: 09-FEB-23
Bologna IT 40138 510(k) STATEMENT
DEVICE: Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)
Zhejiang Rongsheng Industrial Co.,510(k) NO: K220657(Traditional)
ATTN: Wu Bentuan PHONE NO : 86 579 82953477
2Jinheng Rd. SE DECISION MADE: 10-FEB-23
Xiaoshun Town, Jinhua CN 321035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bambino 3, S3 and S3 Swing, U3 and U3 Light, X
Panthera AB 510(k) NO: K220698(Traditional)
ATTN: Fredrik Stantz PHONE NO : 46 8 7615040
Gunnebogatan 26 SE DECISION MADE: 16-FEB-23
Stockholm SE 16353 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTSMedia In Vitro Culture Medium (AM-IVC Medium)
ARTSMedia Denmark ApS 510(k) NO: K220715(Traditional)
ATTN: Lotte Stroebech PHONE NO : 45 25 320825
Kongevejen 149 SE DECISION MADE: 10-FEB-23
Virum DK 2830 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Duoblade
CnC Technologies 510(k) NO: K220996(Traditional)
ATTN: InSang Choi PHONE NO : 82 2 20832200
E1101, Gwang Myeong Technopark, 60SE DECISION MADE: 03-FEB-23
Gwangmyeong-Si KR 14322 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Doctor Tecar Plus, Doctor Tecar Smart
Mectronic Medicale S.r.l. 510(k) NO: K221043(Traditional)
ATTN: Gloria Aloisini PHONE NO : 39 035 656080
Via Orio al Serio 15 SE DECISION MADE: 17-FEB-23
Grassobbio IT 24050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tinnitogram Signal Generator
Goldenear Company, Inc. 510(k) NO: K221168(Traditional)
ATTN: Daehee Lee PHONE NO : 1 661 2071307
24207 Via Perla SE DECISION MADE: 01-FEB-23
Santa Clarita CA 91354 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: extriCARE® 3000 Negative Wound Pressure Therapy System
Alleva Medical Devices 510(k) NO: K221223(Traditional)
ATTN: Max Choi PHONE NO : 714 9873603
1050 W Central Avenue, Unit B SE DECISION MADE: 09-FEB-23
Brea CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
Maine Molecular Quality Controls, 510(k) NO: K221253(Traditional)
ATTN: Joan Gordon PHONE NO : 207 8851072 201
23 Mill Brook Road SE DECISION MADE: 03-FEB-23
Saco ME 04072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpectraWAVE Imaging System
SpectraWAVE Inc 510(k) NO: K221257(Traditional)
ATTN: Farzad Parsaie PHONE NO : 781 3070974
12 Oak Park Drive SE DECISION MADE: 28-FEB-23
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eyer Retinal Camera NM-STD
Phelcom Technologies 510(k) NO: K221329(Traditional)
ATTN: Flávio Pascoal Vieira PHONE NO : 55 163 4133088
Rua José Missali, 820 - Santa FelíSE DECISION MADE: 22-FEB-23
São Carlos BR 13562-405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)
Philips Medizin Systeme Böblingen 510(k) NO: K221348(Traditional)
ATTN: Stefan Breuer PHONE NO : 49 1511 9615514
Hewlett-Packard Str. 2 SE DECISION MADE: 03-FEB-23
Böblingen DE 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wee Bell
wee MEDICAL 510(k) NO: K221356(Traditional)
ATTN: D Preston Smith PHONE NO : 865 5846700
6800 Baum Drive SE DECISION MADE: 02-FEB-23
Knoxville, TN 37919 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: hygh-tec drainage
Creative Balloons GmbH 510(k) NO: K221400(Traditional)
ATTN: Claudia Falk PHONE NO : 49 07254 4039716
Bruchsaler Straße 22 SE DECISION MADE: 09-FEB-23
Waghäusel DE 68753 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DiLumen C1, EZ1 and Tool Mount
Lumendi, LLC 510(k) NO: K221452(Traditional)
ATTN: Dennis Daniels PHONE NO : 203 4632669
253 Post Road West SE DECISION MADE: 10-FEB-23
Westport CT 06880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants
Acuitive Technologies, Inc. 510(k) NO: K221468(Traditional)
ATTN: Matthew Poggie PHONE NO : 201 6612678
50 Commerce Drive SE DECISION MADE: 14-FEB-23
Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATI (Protector Against Tongue Injury)
NeuroVice, LLC 510(k) NO: K221469(Traditional)
ATTN: Ashlyn Sanders PHONE NO : 919 2605023
7928 Woodcross Way SE DECISION MADE: 22-FEB-23
Wake Forest NC 27587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Filter and HME/Filter
Ningbo Huakun Medical Equipment Co510(k) NO: K221472(Traditional)
ATTN: Lei Xi PHONE NO : 86 574 63292569
No.208 Binjiang Road, Cixi High-teSE DECISION MADE: 08-FEB-23
Cixi CN 315301 510(k) STATEMENT
DEVICE: PRIMUS Healthcare Sterilizer (Model PSS11-HC)
PRIMUS Sterilizer Company, LLC 510(k) NO: K221474(Abbreviated)
ATTN: Patrick Hansen PHONE NO : 1 402 3444200 1214
7936 Forest City Road, Suite 100 SE DECISION MADE: 10-FEB-23
Orlando FL 32810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Perifit
X6 Innovations 510(k) NO: K221476(Traditional)
ATTN: Artem Rodionov PHONE NO : 33 6516 65594
128 Rue De La Boétie SE DECISION MADE: 10-FEB-23
Paris FR 75008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlowSaver Blood Return System
Inari Medical, Inc. 510(k) NO: K221483(Traditional)
ATTN: Kaitlyn Weinkauf PHONE NO : 949 4184116
6001 Oak Canyon, Suite 100 SE DECISION MADE: 17-FEB-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer, AVS TL PEEK Spacer, AVS PL PEEK Spacer, AVS AL PEEK Spacer, AVS UniLIF PEEK Spacer, AVS Navigator PEEK Spacer, AVS AS PEEK Spacer, Monterey AL Interbody System, Aleutian IBF System, Capri Corpectomy Cage System, Cascadia Interbody System, Chesapeake Stabilization System, Mojave Expandable Interbody System, Sahara Stabilization System, Santorini Corpectomy Cage System
Stryker Spine 510(k) NO: K221490(Traditional)
ATTN: Renee Norby PHONE NO : 201 7254954
2 Pearl Court SE DECISION MADE: 14-FEB-23
Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anivia SG1000 Pump Console
APMTD, Inc. 510(k) NO: K221491(Traditional)
ATTN: John Sasso PHONE NO : 781 9626274
226 Lowell Street, Unit B16 SE DECISION MADE: 03-FEB-23
Wilmington MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Equashield Closed System Transfer Device
EQUASHIELD Medical Ltd. 510(k) NO: K221513(Traditional)
ATTN: Michal Levy PHONE NO : 972 4 9873737
Ktalav St.1, POB 12 SE DECISION MADE: 17-FEB-23
Migdal Tefen IL 2495900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring
Boston Scientific Corporation 510(k) NO: K221515(Traditional)
ATTN: Tanmay Shukla PHONE NO : 508 6836522
100 Boston Scientific Way SE DECISION MADE: 02-FEB-23
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tanning Lamp
Unilam Co., Ltd. 510(k) NO: K221523(Traditional)
ATTN: Y B Cho PHONE NO : 82 55 3722509
23 Samdong-Ro, Samnam-Myeon, Ulju-SE DECISION MADE: 15-FEB-23
Ulsan Gwangyeogsi KR 44954 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StitchKit
Origami Surgical Inc . 510(k) NO: K221527(Traditional)
ATTN: John Gillespie PHONE NO : 774 5670277
42 Main St. SE DECISION MADE: 14-FEB-23
Madison NJ 07940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClotTriever Thrombectomy System
Inari Medical, Inc. 510(k) NO: K221531(Traditional)
ATTN: Amnon Talmor PHONE NO : 352 5142339
6001 Oak Canyon, Suite 100 SE DECISION MADE: 06-FEB-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3
StringKing 510(k) NO: K221559(Traditional)
ATTN: Thomas Frasca PHONE NO : 1 508 6541988
19100 S Vermont Avenue SE DECISION MADE: 23-FEB-23
Gardena CA 90248 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brainomix 360 e-ASPECTS
Brainomix Limited 510(k) NO: K221564(Traditional)
ATTN: Gwilym Owen PHONE NO : 440 7375 552275
Suite 11-14, Suffolk House, 263 BaSE DECISION MADE: 23-FEB-23
Oxford GB OX2 7HN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source
Schoelly Fiberoptic GmbH 510(k) NO: K221591(Traditional)
ATTN: Sandra Baumann PHONE NO : 0049 7666 908357
Robert-Bosch-Strasse 1-3 SE DECISION MADE: 23-FEB-23
Denzlingen DE 79211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVIEW Lung Nodule CAD
Coreline Soft Co.,Ltd. 510(k) NO: K221592(Traditional)
ATTN: Hyeyi Park PHONE NO : 82 2571 7321
4,5F(Yeonnam-dong), 49, World Cup SE DECISION MADE: 24-FEB-23
Seoul KR 03991 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TytoCare Lung Sounds Analyzer
Tyto Care Ltd. 510(k) NO: K221614(Traditional)
ATTN: Stella Raizelman Perry PHONE NO : 972 72 2210750
14 Beni Gaon Street SE DECISION MADE: 24-FEB-23
Netanya IL 4250803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)
Covidien 510(k) NO: K221629(Traditional)
ATTN: Katherine Y. Choi PHONE NO : 917 8416315
60 Middletown Avenue SE DECISION MADE: 22-FEB-23
North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)
Terragene SA 510(k) NO: K221641(Traditional)
ATTN: Hernando Carrizo PHONE NO : 54 341 5587007
Ruta Nacional No. 9, Km 280, ParquSE DECISION MADE: 28-FEB-23
Alvear AR 2130 510(k) STATEMENT
DEVICE: PROstep(TM) MIS 5mm Chamfer Screw System
Wright Medical Technology 510(k) NO: K221645(Abbreviated)
ATTN: Anna Bushart PHONE NO : 901 6053318
1023 Cherry Road SE DECISION MADE: 17-FEB-23
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Creo Electrosurgical System with NP1 Instrument
Creo Medical Ltd. 510(k) NO: K221672(Traditional)
ATTN: Tiffany Powell PHONE NO : 44 1291 448545
Creo House, Unit 2, Beaufort Park SE DECISION MADE: 14-FEB-23
Chepstow GB NP16 5UH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: External Drainage System
JMED(Shenzhen) Technology Limited 510(k) NO: K221694(Traditional)
ATTN: Anna Xiao PHONE NO : 86 7558 4513706818
7#401, Zhongxing Road, Xiuxin CommSE DECISION MADE: 09-FEB-23
Shenzhen City CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CompuFlo Epidural Computer Controlled Anesthesia System
Milestone Scientific, Inc. 510(k) NO: K221702(Traditional)
ATTN: Arjan Haverhals PHONE NO : 973 5351117
425 Eagle Rock Ave Suite 403 SE DECISION MADE: 25-FEB-23
Roseland NJ 07068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: U2 Total Knee System-PF+
United Orthopedic Corporation 510(k) NO: K221705(Traditional)
ATTN: Lois Ho PHONE NO : 886 3 5773351 2220
No 57, Park Ave 2, Science Park SE DECISION MADE: 28-FEB-23
Hsinchu TW 30075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccuICAS
ArteryFlow Technology Co., Ltd. 510(k) NO: K221711(Traditional)
ATTN: Jianping Xiang PHONE NO : 86 571 86772567
459 Qianmo Road, Suite C1-501, BinSE DECISION MADE: 28-FEB-23
Hangzhou CN 310051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAUS Air Dental Handpiece
Saeshin Precision Co., Ltd. 510(k) NO: K221741(Traditional)
ATTN: Gung San Nam PHONE NO : 82 53 5872345
#52, Secheon-ro 1-gil, Dasa-eup, DSE DECISION MADE: 22-FEB-23
Daegu KR 42921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH
Guangdong OptoMedic Technologies, 510(k) NO: K221781(Traditional)
ATTN: Jane Guo PHONE NO : 86 757 86702920
Suite 503, Building A, Golden VallSE DECISION MADE: 02-FEB-23
Foshan CN 528200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-use Video Pancreaticobiliary Scope, PB Digital Controller
Micro-Tech (Nanjing) Co., Ltd 510(k) NO: K221784(Traditional)
ATTN: Sally He PHONE NO : 86 25 58350006
No. 10 Gaoke Third Road Nanjing NaSE DECISION MADE: 16-FEB-23
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARMONIC 700 Shears
Ethicon Endo-Surgery, LLC 510(k) NO: K221790(Traditional)
ATTN: Nathan Anderson PHONE NO : 1 787 2726144
475 Calle C SE DECISION MADE: 28-FEB-23
Guaynabo PR 00969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
Blue Sky Bio, LLC 510(k) NO: K221845(Abbreviated)
ATTN: Albert Zickmann PHONE NO : 773 7045111___
800 Liberty Drive SE DECISION MADE: 24-FEB-23
Libertyville IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FloNavi Endoscopic Fluorescence Imaging System
Guangdong OptoMedic Technologies, 510(k) NO: K221861(Traditional)
ATTN: Jane Guo PHONE NO : 86 757 86702920
Suite 503, Building A, Golden VallSE DECISION MADE: 18-FEB-23
Foshan CN 528200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Altis Single Incision Sling System
Coloplast A/S 510(k) NO: K221874(Special)
ATTN: Gayatri Ghadge PHONE NO : 612 4223206
1601 West River Road North SE DECISION MADE: 15-FEB-23
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterilization Pouch and Roll
Qianjiang Kingphar Medical Packagi510(k) NO: K221875(Traditional)
ATTN: Zhao Fusong PHONE NO : 86 1334981693
Dongjing Road 23, Yuanlin Office SE DECISION MADE: 13-FEB-23
Qianjiang CN 433100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Delta III Pro
Dornier MedTech America, Inc 510(k) NO: K221903(Traditional)
ATTN: John Hoffer PHONE NO : 770 5146163
1155 Roberts Blvd Suite 100 SE DECISION MADE: 22-FEB-23
Kennesaw GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EmbedMed
3D LifePrints UK Ltd. 510(k) NO: K221943(Traditional)
ATTN: Henry Pinchbeck PHONE NO : 44 07971 172273
The Innovation Hub, Alder Hey ChilSE DECISION MADE: 01-FEB-23
West Derby, Liverpool, Merseyside 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
Ever Global (Vietnam) Enterprise C510(k) NO: K221980(Traditional)
ATTN: Jerry Lin PHONE NO : 84 61 3514022
Long Thanh Industrial Zone SE DECISION MADE: 06-FEB-23
Taman Village VN 810000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYGNUS-C Standalone ACIF System
GS Medical Co. Ltd. 510(k) NO: K222041(Traditional)
ATTN: Sam Camp PHONE NO : 352 3274641
90, Osongsaengmyeong 4-ro Osong-euSE DECISION MADE: 09-FEB-23
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONTAGE Settable, Resorbable Bone Putty
Orthocon, Inc. 510(k) NO: K222063(Traditional)
ATTN: Aniq Darr PHONE NO : 914 3572600
1 Bridge Street - Suite 121 SE DECISION MADE: 03-FEB-23
Irvington NY 10533 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Passeo-35 Xeo Peripheral Dilatation Catheter
BioTronik, Inc. 510(k) NO: K222065(Traditional)
ATTN: Jon Brumbaugh PHONE NO : 888 3450374
6024 Jean Road SE DECISION MADE: 16-FEB-23
Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)
bioMerieux, Inc 510(k) NO: K222073(Traditional)
ATTN: Kyle J. Olney PHONE NO : 314 7318666
595 Anglum Rd. SE DECISION MADE: 09-FEB-23
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
Top Glove Medical (Thailand) Co., 510(k) NO: K222129(Traditional)
ATTN: Shahana Parveen Binti RidzamPHONE NO : 66 744 410000
188, 189, 190 Moo 5 KanchanawanichSE DECISION MADE: 10-FEB-23
Amphur Sadao TH 90320 510(k) STATEMENT
DEVICE: Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)
Microlife Intellectual Property Gm510(k) NO: K222153(Traditional)
ATTN: Gerhard Frick PHONE NO : 41 717 277000
Espenstrasse 139 SE DECISION MADE: 03-FEB-23
Widnau CH 9443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Saneso Lens Wash Bottle Assembly (SAN-LWB-A)
Saneso, Inc. 510(k) NO: K222173(Traditional)
ATTN: Nitesh Ratnakar PHONE NO : 412 2507621
One Oxford Center, 301 Grant StreeSE DECISION MADE: 27-FEB-23
Pittsburg PA 15219 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Introducer Sheath Kits
Beijing Demax Medical Technology C510(k) NO: K222184(Traditional)
ATTN: Anny Zhang PHONE NO : 86 010 59771799
101, Floor 1-3, 13-7A JingshengnanSE DECISION MADE: 21-FEB-23
Beijing CN 101102 510(k) STATEMENT
DEVICE: Implant Direct Dental Implant Systems Portfolio - MR Conditional
Implant Direct Sybron Manufacturin510(k) NO: K222211(Traditional)
ATTN: Reina Choi PHONE NO : 818 3073132
3050 East Hillcrest Drive SE DECISION MADE: 02-FEB-23
Thousand Oaks CA 91362 510(k) STATEMENT
DEVICE: EON
Dominion Aesthetic Technologies, I510(k) NO: K222226(Traditional)
ATTN: Ahmed Mohammed PHONE NO : 763 4394602
2431 Aloma Avenue Suite 300 SE DECISION MADE: 17-FEB-23
Winter Park FL 32792 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPLORER AIR® II
SurgVision GmbH 510(k) NO: K222240(Traditional)
ATTN: Daniela Mahan PHONE NO : 49 89 44238300
Kistlerhof Strasse 70, Building 79SE DECISION MADE: 28-FEB-23
Munich DE 81379 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hailie Sensor NF0110
Adherium (NZ) Ltd 510(k) NO: K222247(Traditional)
ATTN: Tara Creaven-Capasso PHONE NO : 61 477 543567
Level 11, 16 Kingston Street SE DECISION MADE: 08-FEB-23
Auckland NZ 1010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEONA 1.5T MRI System
Time Medical Limited 510(k) NO: K222259(Abbreviated)
ATTN: Nick Tse PHONE NO : 852 2156 1711 119
Flat/Rm 301, 3/F 20E, 20 Science PSE DECISION MADE: 21-FEB-23
Shatin, Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Verisafe Safety sterile needles
Promisemed Hangzhou Meditech Co., 510(k) NO: K222271(Traditional)
ATTN: Zearou Yang PHONE NO : 86 571 88772985
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 15-FEB-23
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bloomlife MFM-Pro
Bloom Technologies NV 510(k) NO: K222327(Traditional)
ATTN: Roberto Cunha PHONE NO : 1 561 3059029
Schiepse Bos 6 SE DECISION MADE: 13-FEB-23
Genk BE 3600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arrow 0.2 Micron Flat Filter, GVS
Arrow International, LLC 510(k) NO: K222341(Traditional)
ATTN: Ann Metz PHONE NO : 262 9559774
3015 Carrington Mill Blvd SE DECISION MADE: 13-FEB-23
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Visionbody
VB Technologies AG 510(k) NO: K222386(Traditional)
ATTN: Jorge Millan PHONE NO : 786 4165587
Baarerstrasse 12 SE DECISION MADE: 24-FEB-23
Zug CH 6300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEUS System
iRhythm Technologies, Inc. 510(k) NO: K222389(Traditional)
ATTN: Vishal Kanani PHONE NO : 213 4000963
699 8th Street SE DECISION MADE: 15-FEB-23
San Francisco CA 94103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Care Team Portal
Vivify Health, Inc. 510(k) NO: K222398(Traditional)
ATTN: Tracey Fox PHONE NO : 763 3309208___
7201 Bishop Rd. Suite #E200 SE DECISION MADE: 06-FEB-23
Plano TX 75024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polaris Valve Electronic Reading Instrument
Sophysa 510(k) NO: K222422(Traditional)
ATTN: Philippe Negre PHONE NO : 033 1 69353500
05 Rue Guy Moquet SE DECISION MADE: 02-FEB-23
Orsay FR 91400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAVE GBR
Dentis Co., Ltd. 510(k) NO: K222451(Traditional)
ATTN: Gyu Ri Kim PHONE NO : 82 53 5893541
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 07-FEB-23
Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PuraStat
3-D Matrix, Inc. 510(k) NO: K222481(Traditional)
ATTN: Lisa Spirio PHONE NO : 617 8756204
1234 Chestnut Street, Suite 205 SE DECISION MADE: 28-FEB-23
Newton MA 02464 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mobility Scooter (Models: W3431Q, W3431R)
Zhejiang Innuovo Rehabilitation De510(k) NO: K222507(Traditional)
ATTN: Leo Zheng PHONE NO : 86 1835 8936043
No.196 Industry Road, Hengdian MovSE DECISION MADE: 28-FEB-23
Dongyang CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Glass Ceramics
Yilink (Tianjin) Biotechnology Co.510(k) NO: K222513(Traditional)
ATTN: Yaqiong Zhu PHONE NO : 086 022 88522665
No 9 Kaituo Road Balitai Town JinnSE DECISION MADE: 10-FEB-23
Tianjin CN 300350 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COPAL knee moulds
Heraeus Medical GmbH 510(k) NO: K222570(Traditional)
ATTN: Alexander Peczka PHONE NO : 49 6181 352964
Philipp-Reis-Str, 8-13 SE DECISION MADE: 04-FEB-23
Wehrheim DE 61273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Simparo Anchor Line Fixation System
Simparo, Inc. 510(k) NO: K222574(Traditional)
ATTN: Chris Harber PHONE NO : 953 9330646
1125 Corporate Drive North SE DECISION MADE: 04-FEB-23
Mobile AL 36607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Belun Sleep System BLS-100
Belun Technology Company Limited 510(k) NO: K222579(Traditional)
ATTN: Leung Lap Wai Lydia PHONE NO : 852 3706 5640
Unit 218, 2/F, Core Building 2, NoSE DECISION MADE: 23-FEB-23
Sha Tin CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1
iWEECARE Co., Ltd. 510(k) NO: K222588(Traditional)
ATTN: Julia Yang PHONE NO : 886 2 28918636
1F., No. 11, Ln. 382, Zhonghe St.,SE DECISION MADE: 17-FEB-23
Taipei City TW 112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S90 Exp Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp. 510(k) NO: K222596(Traditional)
ATTN: Toki Wu PHONE NO : 86 755 26722890
Room 201 & 202, 12th Building, SheSE DECISION MADE: 10-FEB-23
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Infusion Bag for Parenteral Nutrition
Beijing L&Z Medical Technology Dev510(k) NO: K222622(Traditional)
ATTN: QiuHong Dong PHONE NO : 86 10 69956211
N0.8, M2-5 Block, Xinggu IndustriaSE DECISION MADE: 16-FEB-23
Beijing CN 101200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DeltaScan Patch
Prolira B.V. 510(k) NO: K222671(Traditional)
ATTN: Rutger O. van Merkerk PHONE NO : 0031__ 85 0601656
Padualaan 8 SE DECISION MADE: 02-FEB-23
Utrecht NL NL-6825 BS 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DeltaScan Monitor
Prolira B.V. 510(k) NO: K222680(Traditional)
ATTN: Rutger O. van Merkerk PHONE NO : 0031 6 47762936
Padualaan 8 SE DECISION MADE: 02-FEB-23
Utrecht NL 3584 CH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIRA Model 2
Dermal Photonics Corp 510(k) NO: K222685(Traditional)
ATTN: Felix Feldchtein PHONE NO : 781 4511703
153 Andover St, Ste 111 SE DECISION MADE: 08-FEB-23
Danvers MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: troCarWash™ System
Biotex Inc. 510(k) NO: K222695(Traditional)
ATTN: Wade Munsch PHONE NO : 713 7410111 208
114 Holmes Rd. SE DECISION MADE: 17-FEB-23
Houston TX 77045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED Light Therapy Device, KN-7000L
Xuzhou Kernel Medical Equipment Co510(k) NO: K222751(Traditional)
ATTN: Cuiling Xi PHONE NO : 86 516 87732208
Kernel Mansion, Economic DevelopmeSE DECISION MADE: 01-FEB-23
Xuzhou CN 221004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uMR 680
Shanghai United Imaging Intelligen510(k) NO: K222755(Traditional)
ATTN: Xin GAO PHONE NO : 86 21 67076888 5386
No. 2258 Chengbei Road, Jiading DiSE DECISION MADE: 16-FEB-23
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clarus Viewer
Clarus Viewer Corporation 510(k) NO: K222757(Traditional)
ATTN: Steve Thomas PHONE NO : 256 9229300
5030 Bradford Drive NW; Building 2SE DECISION MADE: 24-FEB-23
Huntsville AL 35805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oncospace
Oncospace, Inc. 510(k) NO: K222803(Traditional)
ATTN: Sigrid Schoepel PHONE NO : 608 3353176 ______
1812 Ashland Ave., Suite 100k SE DECISION MADE: 02-FEB-23
Baltimore MD 21205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Garment Electrodes
Tone-A-Matic International Inc. 510(k) NO: K222863(Traditional)
ATTN: Manuel Chuck PHONE NO : 905 5019290
145 Traders East, Unit 18 SE DECISION MADE: 01-FEB-23
Mississauga CA L5Z-3L3 510(k) STATEMENT
DEVICE: Arm Blood Pressure Monitor
Andon Health Co., Ltd. 510(k) NO: K222869(Abbreviated)
ATTN: Liu Yi PHONE NO : 86 22 87611660 9223
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 15-FEB-23
Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K222928(Traditional)
ATTN: Zhang Wei PHONE NO : 86 755 81885655
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 07-FEB-23
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcuPebble OX100
Acurable Limited 510(k) NO: K222950(Traditional)
ATTN: Esther Rodriguez-Villegas PHONE NO : 447 939 036867
Finsgate, 5-7 Cranwood Street SE DECISION MADE: 03-FEB-23
London GB EC1V 9EE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
Xenta Biomedical Science Co., Ltd.510(k) NO: K222955(Traditional)
ATTN: Huang Ling PHONE NO : 86 20 31707187
Building C5, 9th Floor, Rm 901, NoSE DECISION MADE: 06-FEB-23
Guangzhou CN 510535 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LVivo IQS
DiA Imaging Analysis Ltd 510(k) NO: K222970(Traditional)
ATTN: Michal Yaacobi PHONE NO : 972 77 7648318
77 Haenergia Street SE DECISION MADE: 01-FEB-23
Beer-Sheva IL 8470912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device; ULTRABUTTON TIB SMALL Adjustable Fixation Device; ULTRABUTTON TIB MEDIUM Adjustable Fixation Device; ULTRABUTTON TIB LARGE Adjustable Fixation Device
Smith & Nephew Inc 510(k) NO: K222971(Traditional)
ATTN: Dongeun LoPresti PHONE NO : 724 8318194
150 Minuteman Road SE DECISION MADE: 17-FEB-23
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip
MacroMedics BV 510(k) NO: K222977(Traditional)
ATTN: Elizabeth Hajos PHONE NO : 31 182 389777
Oostbaan 670 SE DECISION MADE: 17-FEB-23
Moordrecht NL 2841 ML 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SC HONKYTONK PTCA Balloon Dilatation Catheter
Sino Medical Sciences Technology I510(k) NO: K223022(Traditional)
ATTN: Jianhua Sun PHONE NO : 86 022 59862900
TEDA Biopharm Research, #5, 4th StSE DECISION MADE: 15-FEB-23
Tianjin CN 300457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
Northeast Scientific, Inc. 510(k) NO: K223026(Traditional)
ATTN: Matt Farley PHONE NO : 203 7562111
2142 Thomaston Ave. SE DECISION MADE: 03-FEB-23
Waterbury CT 06704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare510(k) NO: K223028(Traditional)
ATTN: Xin Gao PHONE NO : 86 216707 68885386
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 16-FEB-23
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Access Cortisol
Beckman Coulter, Inc 510(k) NO: K223038(Traditional)
ATTN: Kuljeet Kaur PHONE NO : 1 952 4651914
1000 Lake Hazeltine Drive SE DECISION MADE: 08-FEB-23
Chaska MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpert® FII & FV
Cepheid® 510(k) NO: K223046(Special)
ATTN: Suzette Chance PHONE NO : 262 6231775
904 Caribbean Drive SE DECISION MADE: 15-FEB-23
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pre-Formed Silicone Block
International Medical Devices, Inc510(k) NO: K223051(Traditional)
ATTN: Dr. James Elist PHONE NO : 310 6522600
717 North Maple Drive SE DECISION MADE: 03-FEB-23
Beverly Hills CA 90210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JAWS Nitinol Staple System
Paragon 28, Inc. 510(k) NO: K223056(Traditional)
ATTN: Haylie Hertz PHONE NO : 303 7200017
14445 Grasslands Dr. SE DECISION MADE: 16-FEB-23
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ogmend® Implant Enhancement System
Woven Orthopedic Technologies 510(k) NO: K223075(Traditional)
ATTN: Brandon Bendes PHONE NO : 860 2591262
63 Center Street #3a SE DECISION MADE: 27-FEB-23
Manchester CT 06040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 8X-10-6XXX Camera Head
Santa Barbara Imaging Systems 510(k) NO: K223116(Traditional)
ATTN: Jim Candy PHONE NO : 805 7702110
340 Storke Road, Suite 101 SE DECISION MADE: 28-FEB-23
Goleta CA 93117 510(k) STATEMENT
DEVICE: EVOLUTION SPINE Interbody System
Evolution Spine 510(k) NO: K223146(Traditional)
ATTN: Todd Wallenstein PHONE NO : 571 5947409
2300 N. Haskell Ave SE DECISION MADE: 07-FEB-23
Dallas TX 75204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXY-1 System
Abiomed Inc. 510(k) NO: K223161(Traditional)
ATTN: Ken Ryder PHONE NO :
22 Cherry Hill Drive SE DECISION MADE: 23-FEB-23
Danvers MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nerivio
Theranica Bioelectronics ltd 510(k) NO: K223169(Traditional)
ATTN: Alon Ironi PHONE NO : 972 72 3909763
4 Ha-Omanutst. Poleg Industrial PaSE DECISION MADE: 06-FEB-23
Netanya IL 4250574 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-Pac Expandable LLIF Cage System
Expanding Innovations, Inc. 510(k) NO: K223174(Traditional)
ATTN: Robert Jaramillo PHONE NO : 925 8192257___
110 Pioneer Way, Suite 1 SE DECISION MADE: 14-FEB-23
Mountain View CA 94041-1519 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
Penumbra, Inc. 510(k) NO: K223186(Traditional)
ATTN: Deanna Kimlinger PHONE NO : 925 2129088
One Penumbra Place SE DECISION MADE: 13-FEB-23
Alameda CA 95132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Glass Ceramic
Shenzhen Xiangtong Co.,Ltd. 510(k) NO: K223194(Traditional)
ATTN: Xue Gong PHONE NO : 86____ 137___ 60477635
2nd F., 1st Bldg., West Area, HongSE DECISION MADE: 10-FEB-23
Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety Lancet
Suzhou Zhenwu Medical Co., Ltd. 510(k) NO: K223208(Traditional)
ATTN: Kai Xu PHONE NO : 86 0512 63230688
No. 248, Chijiawan Road, Wujiang DSE DECISION MADE: 10-FEB-23
Suzhou CN 215214 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elekta Unity
Elekta Solutions AB 510(k) NO: K223209(Traditional)
ATTN: Melinda Smith PHONE NO : 678 2317791
Kungstensgatan 18 Box 7593 SE DECISION MADE: 23-FEB-23
Stockholm SE SE10393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Symphony Thrombectomy System
Truvic Medical Inc. 510(k) NO: K223216(Traditional)
ATTN: Vida Sollanek PHONE NO : 917 8928653
1359 Dell Ave SE DECISION MADE: 23-FEB-23
Campbell CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BENCOX Mirabo Z Cup Cortinium
Corentec Co., Ltd. 510(k) NO: K223223(Special)
ATTN: Songe Kang PHONE NO : 82 414 107117
12, Yeongsanhong 1-gil, Ipjang-MyeSE DECISION MADE: 27-FEB-23
Cheonan-si KR 31056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 8ch T/R Knee Coil
Shenzhen RF Tech Co., Ltd. 510(k) NO: K223225(Traditional)
ATTN: Gary Wang PHONE NO : 0086 755 26641989__ 113
2-F,BLD4 Juhui Industrial Park, TiSE DECISION MADE: 14-FEB-23
Shenzhen CN 518132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOSAIQ® OIS (Oncology Information System)
Elekta Solutions AB 510(k) NO: K223229(Traditional)
ATTN: Melinda Smith PHONE NO : 1 678 2317791
Kungstensgatan 18 Box 7593 SE DECISION MADE: 23-FEB-23
Stockholm SE SE10393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ti-Largo Cervical Interbody System
FloSpine 510(k) NO: K223231(Traditional)
ATTN: Peter Harris PHONE NO : 561 7053080
3651 FAU Blvd., Suite 400 SE DECISION MADE: 24-FEB-23
Boca Raton FL 33431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Monaco RTP System
Elekta Solutions AB 510(k) NO: K223233(Traditional)
ATTN: Melinda Smith PHONE NO : 1 678 2317791
Kungstensgatan 18 Box 7593 SE DECISION MADE: 23-FEB-23
Stockholm SE SE10393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pro-Tx Endorectal Balloon (PROT-25)
DxTx Medical, Inc. 510(k) NO: K223249(Abbreviated)
ATTN: Paul Lawson PHONE NO : 412 5963221
639 Alpha Dr SE DECISION MADE: 10-FEB-23
Pittsburgh PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)
Arumdentistry Co., Ltd. 510(k) NO: K223253(Traditional)
ATTN: Hyang Mi Lee PHONE NO : 82 42 9353644
23 Gukjegwahak 11-Ro, Yuseong-gu SE DECISION MADE: 27-FEB-23
Daejeon KR 34002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Renuvion® APR Handpiece
Apyx Medical Corporation 510(k) NO: K223262(Traditional)
ATTN: Mark D. Evans PHONE NO : 856 5245037
(formerly Bovie Medical CorporatioSE DECISION MADE: 23-FEB-23
Clearwater FL 33760-4004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prevena Plus 125 Therapy Unit
3M 510(k) NO: K223263(Traditional)
ATTN: Teri Feeley PHONE NO : 210 4591952___
6203 Farinon Dr. SE DECISION MADE: 13-FEB-23
San Antionio TX 78247 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SurBlate Ablation System
Mima-Pro Scientific Inc. 510(k) NO: K223272(Third Party - Traditional)
ATTN: Jim Elliott PHONE NO : 1 604 2090443
Unit 180, 11611 No. 5 Road SE DECISION MADE: 28-FEB-23
Richmond CA V7A 4E8 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SutureLoc™ Implant
Arthrex Inc. 510(k) NO: K223284(Traditional)
ATTN: Erikka Edwardsen PHONE NO : 1 239 6435553 70422
1370 Creekside Boulevard SE DECISION MADE: 02-FEB-23
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Videa Perio Assist
VideaHealth, Inc. 510(k) NO: K223296(Traditional)
ATTN: Adam Foresman PHONE NO : 630 6700771
179 South Street Floor 5 SE DECISION MADE: 06-FEB-23
Boston MA 02111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
Shandong Intco Medical Products Co510(k) NO: K223298(Traditional)
ATTN: Min Gao PHONE NO : 86 536 61368 ______
9888 Qiwang Road, Naoshan IndustriSE DECISION MADE: 22-FEB-23
Qingzhou CN 2625000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
Xiamen Probtain Medical Technology510(k) NO: K223304(Traditional)
ATTN: Jianli Kang PHONE NO : 86 592 7557106___
4th Floor, No.1 Building, No.6 Ji'SE DECISION MADE: 08-FEB-23
Xiamen CN 361100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Aesthetic Cannula and Hypodermic Needle
Shanghai Kindly Enterprise Develop510(k) NO: K223327(Traditional)
ATTN: Liu Hualong PHONE NO : 86 021 69118232
No.658 Gaochao Road SE DECISION MADE: 16-FEB-23
Shanghai CN 201803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Certas Plus Programmable Valves
Integra LifeSciences Production Co510(k) NO: K223330(Traditional)
ATTN: Amanda Erwin PHONE NO : 609 6279053
11 Cabot Boulevard SE DECISION MADE: 01-FEB-23
Mansfield MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Toothsi, Smilealigners
AMPA Orthodontics Private Limited 510(k) NO: K223338(Traditional)
ATTN: Manjul Jain PHONE NO : 91____ 982 0340245
1st Floor Empire Plaza B Wing, LalSE DECISION MADE: 09-FEB-23
Mumbai IN 400083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device
4WEB Medical, Inc. 510(k) NO: K223362(Traditional)
ATTN: Lewis Harrison PHONE NO : 800 2857090
2801 Network Blvd., Suite 620 SE DECISION MADE: 02-FEB-23
Frisco TX 75034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeatNick Heel Safety Lancet
Facet Technologies LLC 510(k) NO: K223370(Traditional)
ATTN: James Bonds PHONE NO : 770 5906462
3900 North Commerce Drive SE DECISION MADE: 13-FEB-23
Atlanta GA 30344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
Samsung Medison Co., Ltd. 510(k) NO: K223387(Traditional)
ATTN: Ju Jee Young PHONE NO : 82 2 21940861
3366, Hanseo-ro, Nam-myeon SE DECISION MADE: 13-FEB-23
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVCON (TM) Screw System
Voom Medical Devices, Inc. 510(k) NO: K223392(Traditional)
ATTN: Neal M Blitz PHONE NO : 212 7764250
800A 5th Avenue, Suite #403 SE DECISION MADE: 28-FEB-23
New York City NY 10065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Luna Dental Implant System
Shinhung MST Co., Ltd 510(k) NO: K223395(Traditional)
ATTN: Sun Ho Lee PHONE NO : 82 33 7301901
110-2, Donghwagongdan-ro, Munmak-ESE DECISION MADE: 03-FEB-23
Wonju-Si KR 26365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rapid RV/LV
iSchema View Inc. 510(k) NO: K223396(Traditional)
ATTN: James Rosa PHONE NO : 303 7043374
1120 Washington Ave., Ste 200 SE DECISION MADE: 01-FEB-23
Golden CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartRelease Endoscopic Soft Tissue Release System
MicroAire Surgical Instruments 510(k) NO: K223406(Traditional)
ATTN: Glenn Gerstenfeld PHONE NO : 434 9758344
3590 Grand Forks Blvd SE DECISION MADE: 02-FEB-23
Charlottesville VA 22911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Versana Essential
GE Medical Systems Ultrasound and 510(k) NO: K223407(Traditional)
ATTN: Bush Lee PHONE NO : 262 3099429
LLC 9900 W. Innovation Drive SE DECISION MADE: 15-FEB-23
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pisces™-SA STANDALONE ALIF Interbody System
Osseus Fusion Systems 510(k) NO: K223413(Traditional)
ATTN: Jonathan Rosen PHONE NO : 888 3305960
1931 Greenville Ave Suite 200 SE DECISION MADE: 10-FEB-23
Dallas TX 75206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MD.ai Viewer
MDAI Inc 510(k) NO: K223425(Traditional)
ATTN: Leon Chen PHONE NO : 1 917 7251883
110 Wall Street SE DECISION MADE: 10-FEB-23
New York NY 10005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TELIGEN System Peripheral Motor Nerve Stimulation Indications
Medos International, SARL 510(k) NO: K223438(Traditional)
ATTN: Daria Bochenek PHONE NO : 41 79 7191702
Chemin Blanc 38 SE DECISION MADE: 10-FEB-23
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNA Victor
GE Healthcare (Tianjin) Company Li510(k) NO: K223439(Traditional)
ATTN: Huande Li PHONE NO : 86 181 01131237
No. 266 Jingsan Road,Tianjin AirpoSE DECISION MADE: 13-FEB-23
Tianjin CN 300308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Blue Nitrile Examination Glove
S&S Glove Corporation 510(k) NO: K223444(Traditional)
ATTN: Poppy Farrah Rossa PHONE NO : 84 283872 5999
Lot 4, D6 Street, Dat Do I IndustrSE DECISION MADE: 06-FEB-23
Ba Ria-Vung Tau VN VN790000 510(k) STATEMENT
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: K223466(Special)
ATTN: Carroll Martin PHONE NO : 440 3586259
5976 Heisley Road SE DECISION MADE: 17-FEB-23
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Isolation Gown
Nanning TECBOD Biological Technolo510(k) NO: K223467(Traditional)
ATTN: Bing Yao Chen PHONE NO : 0086 1395 9211156
Room 601 Fool 6, B2 Building, No. SE DECISION MADE: 10-FEB-23
Naning CN 530033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PMMA Blocks for Dental Use
Aidite (Qinhuangdao) Technology Co510(k) NO: K223477(Traditional)
ATTN: Chen Yingying PHONE NO : 86 335 8587198
No.56 Tianchi Road, Economic and TSE DECISION MADE: 16-FEB-23
Qinhuangdao CN 066004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin
bioMerieux, Inc 510(k) NO: K223478(Traditional)
ATTN: Cherece L. Jones PHONE NO : 314 7318684
595 Anglum Rd. SE DECISION MADE: 16-FEB-23
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)
bioMerieux, Inc 510(k) NO: K223481(Traditional)
ATTN: Jared Bronson PHONE NO : 314 7318799
595 Anglum Rd. SE DECISION MADE: 03-FEB-23
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eFOLDi Scooter, Lite
SunTech UK Ltd. 510(k) NO: K223492(Traditional)
ATTN: Sumi Wang PHONE NO : 44 0203 1435168
25 Ormside Way, Holmethorpe IndustSE DECISION MADE: 22-FEB-23
Redhill GB RH1 2LW 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spectrum Saliva Collection Device
Spectrum Solutions, LLC 510(k) NO: K223497(Traditional)
ATTN: Katie Compton PHONE NO : 801 7198558
12248 South Lone Peak Pkwy, Ste 10SE DECISION MADE: 17-FEB-23
Draper UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03
MorLaser Shenzhen Co., Ltd. 510(k) NO: K223524(Traditional)
ATTN: Janny Shao PHONE NO : 86 136 32750965
313, 314, 315 & 4th Floor, BuildinSE DECISION MADE: 16-FEB-23
Shenzhen CN 518108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FreeStyle Libre 2 System, FreeStyle Libre 3 System
Abbott Diabetes Care Inc. 510(k) NO: K223537(Traditional)
ATTN: Simon Yuan PHONE NO : 510 8644710___
1360 South Loop Road SE DECISION MADE: 21-FEB-23
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED light therapy mask (FM-01, FM-02, FM-03)
Guangdong Newdermo Biotech Co.,Ltd510(k) NO: K223544(Traditional)
ATTN: Annie Cai PHONE NO : 86 020 311056 ______
Building C28. Huachuang IndustrialSE DECISION MADE: 23-FEB-23
Guangzhou CN 511450 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APRO 70 Catheter and Alembic Aspiration Tubing
Alembic, LLC 510(k) NO: K223545(Traditional)
ATTN: Lisa Yen PHONE NO : 1 650 3885087
627 National Ave. SE DECISION MADE: 17-FEB-23
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)
Nephron Pharmaceuticals Corporatio510(k) NO: K223559(Third Party - Abbreviated)
ATTN: Lou Kennedy PHONE NO : 1 803 5693110
4500 12th Street Extension SE DECISION MADE: 09-FEB-23
West Columbia SC 26172 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MectaLock TI Triple Loaded Suture Anchor
Medacta International S.A. 510(k) NO: K223582(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 24-FEB-23
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)
Ranfac Corporation 510(k) NO: K223612(Special)
ATTN: Eric Kreuz PHONE NO : 508 5884400___
30 Doherty Avenue SE DECISION MADE: 21-FEB-23
Avon MA 02322 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD
Shenzhen Ulike Smart Electronics C510(k) NO: K223618(Traditional)
ATTN: Shane Xie PHONE NO : 86 18 600825411
No.8, Keyuan Road, Yuehai Sub-distSE DECISION MADE: 28-FEB-23
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PreView-III™ Anterior Cervical Plate System
Nexus Spine, LLC 510(k) NO: K223627(Traditional)
ATTN: Jared Crocker PHONE NO : 801 7028585
2825 East Cottonwood Parkway SuiteSE DECISION MADE: 02-FEB-23
Salt Lake City UT 84121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Verifine® Ease Lancing Device, Verifine® Lancing Device
Promisemed Hangzhou Meditech Co., 510(k) NO: K223643(Traditional)
ATTN: Zearou Yang PHONE NO : 86 571 88772985
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 21-FEB-23
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cook® Spectrum® 2 MRC Central Venous Catheter
Cook Advanced Technologies 510(k) NO: K223648(Traditional)
ATTN: Matthew Waninger PHONE NO : 765 2694190
1400 Cumberland Avenue SE DECISION MADE: 03-FEB-23
West Lafayette IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AmeriWater MediQA Reverse Osmosis System (MSP3HF)
AmeriWater, Llc 510(k) NO: K223656(Special)
ATTN: Brian Bowman PHONE NO : 937 4618833
3345 Stop 8 Rd SE DECISION MADE: 13-FEB-23
Dayton OH 45414 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Syringes for Single Use
Shanghai Kindly Enterprise Develop510(k) NO: K223678(Traditional)
ATTN: Amy Li PHONE NO : 86 1572 1449974
No. 658 Gaochao Road SE DECISION MADE: 09-FEB-23
Shanghai CN 201803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Access AMH
Beckman Coulter Inc 510(k) NO: K223679(Traditional)
ATTN: Kate Oelberg PHONE NO : 1 612 4317315
1000 Lake Hazeltine Drive SE DECISION MADE: 03-FEB-23
Chaska MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eneka Pro
TermoSalud 510(k) NO: K223680(Traditional)
ATTN: Cristina Cifuentes Pantoja PHONE NO : 34 985 167547____
Calle Ataulfo Friera Tarfe, 8-3321SE DECISION MADE: 10-FEB-23
Gijon ES 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Protective Masks
Qinhuangdao Taizhi Medical Technol510(k) NO: K223686(Traditional)
ATTN: Fan Xifan PHONE NO : 86____ 133 83659307
No.5, Small and Medium EnterprisesSE DECISION MADE: 07-FEB-23
Qinhuangdao CN 066000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4
Biosense Webster, Inc. 510(k) NO: K223733(Traditional)
ATTN: Phuong Park PHONE NO : 949 9234238
31 Technology Drive, Suite 200 SE DECISION MADE: 16-FEB-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K223735(Special)
ATTN: Sulgue Choi PHONE NO : 425 2819898
22010 South East 51st Street SE DECISION MADE: 06-FEB-23
Issaquah WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex SynergyID Endoscopic Imaging System
Arthex Inc. 510(k) NO: K223759(Traditional)
ATTN: Troy Brooks PHONE NO : 1 239 6435553
1370 Creekside Boulevard SE DECISION MADE: 24-FEB-23
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OIC Intramedullary Screw System
Orthopaedic Implant Company 510(k) NO: K223761(Traditional)
ATTN: Douglas Fulton PHONE NO : 775 6368281
770 Smithridge Dr. #400 SE DECISION MADE: 13-FEB-23
Reno NV 89502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVISION™ NAV Ultrasound Catheter
Biosense Webster, Inc. 510(k) NO: K223766(Traditional)
ATTN: Sheba Chacko PHONE NO : 949 4506058
31 Technology Drive, Suite 200 SE DECISION MADE: 16-FEB-23
Irvine CA 90618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System
Stryker Leibinger GmbH & Co. KG 510(k) NO: K223767(Traditional)
ATTN: Megan B Guilbault PHONE NO : 401 2416152
Bötzinger Straße 41 SE DECISION MADE: 13-FEB-23
Freiburg Baden-Wurttemberg DE D-7510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonopet 1Q 3 7cm 1Q Large
Stryker Corporation 510(k) NO: K223770(Traditional)
ATTN: Thomas Flannelly PHONE NO : 353 87 6487949___
1941 Stryker Way SE DECISION MADE: 16-FEB-23
Kalamazoo MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMPOWR™ blade stem
Encore Medical LLC 510(k) NO: K223779(Traditional)
ATTN: Trey Thorsen PHONE NO : 850 4503932
9800 Metric Blvd Ste 200 SE DECISION MADE: 13-FEB-23
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orthex External Fixation System
OrthoPediatrics Corp. 510(k) NO: K223786(Traditional)
ATTN: Yan Li PHONE NO : 574 2670864
2850 Frontier Drive SE DECISION MADE: 10-FEB-23
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neuro20 Pro System
Neuro20 Technologies 510(k) NO: K223797(Third Party - Traditional)
ATTN: Dennis Schmitt PHONE NO : 917___ 5036876
3802 Spectrum Blvd Suite 116E SE DECISION MADE: 23-FEB-23
Tampa FL 33626 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Glidewell TuffSplint™ Appliance Resin
Prismatik Dentalcraft, Inc. 510(k) NO: K223798(Traditional)
ATTN: Jiahe Li PHONE NO : 949 2223516
2144 Michelson Drive SE DECISION MADE: 17-FEB-23
Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
SB-Kawasumi Laboratories, Inc. 510(k) NO: K223810(Special)
ATTN: Shiro Agehama PHONE NO : 81 44 5899750
3-25-4 Tonomachi, Kawasaki-Ku SE DECISION MADE: 24-FEB-23
Kawasaki-Shi JP 210-8602 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE DROP Lancing Device
STAT Medical Devices 510(k) NO: K223815(Traditional)
ATTN: Hemel Mariano PHONE NO : 305 9450011 312___
2056 N.E. 153rd Street SE DECISION MADE: 15-FEB-23
North Miami Beach FL 33162 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EzDent-i / E2 / Prora View/ Smart M Viewer
Ewoosoft Co., Ltd 510(k) NO: K223820(Traditional)
ATTN: Young Seok Kim PHONE NO : 82 31 80156172
801-ho, Vatechnetworks Bldg., 13, SE DECISION MADE: 17-FEB-23
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivid S60N, Vivid S70N
GE Medical System Ultrasound and P510(k) NO: K223832(Traditional)
ATTN: Lee Bush PHONE NO : 262 3099429
LLC 9900 W. Innovation Drive SE DECISION MADE: 16-FEB-23
Wauwatosa WI 55226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VySpan™ PCT System
Vy Spine, LLC 510(k) NO: K223852(Special)
ATTN: Jordan Hendrickson PHONE NO : 866 4897746
2236 Capital Circle NE, Suite 103-SE DECISION MADE: 24-FEB-23
Tallahassee FL 32308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl
Rhino Health Inc. 510(k) NO: K223859(Traditional)
ATTN: Mark Lee PHONE NO : 1 833 8988989
309 A East, Route 66 SE DECISION MADE: 13-FEB-23
Church Rock NM 87311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMR Shoulder System
LimaCorporate S.p.A. 510(k) NO: K223876(Traditional)
ATTN: Francesca Marello PHONE NO : 39 04 32945511
Via Nazionale 52 SE DECISION MADE: 03-FEB-23
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELITONE Urge Urinary Incontinence Device
Elidah Inc 510(k) NO: K223884(Traditional)
ATTN: Gloria Kolb PHONE NO : 978 4354324
810 Main St. Ste C SE DECISION MADE: 24-FEB-23
Monroe CT 06468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cobra Catheter System
Endovascular Engineering 510(k) NO: K223891(Traditional)
ATTN: Debra Cogan PHONE NO : 408 5150820
3925 Bohannon Drive, Suite 300 SE DECISION MADE: 15-FEB-23
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Excipio LV Thrombectomy Device
Contego Medical Inc. 510(k) NO: K223897(Traditional)
ATTN: Jim Clossick PHONE NO : 1 305 6071708
3801 Lake Boone Trail, Suite 100 SE DECISION MADE: 17-FEB-23
Raleigh NC 27607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: babyLance Safety Heelstick (BLM, BLN, BLP)
Clinical Innovations, LLC 510(k) NO: K223900(Traditional)
ATTN: Alex Garrett PHONE NO : 801 2688200 ______
747 West 4170 South SE DECISION MADE: 24-FEB-23
Murray UT 84123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atomica Planner
Atomica Technology, Inc. 510(k) NO: K230012(Third Party - Traditional)
ATTN: Yahia Megahed PHONE NO : 1 415 2750302
6445 Powers Ferry Rd. NW SE DECISION MADE: 02-FEB-23
Atlanta GA 30339 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BriefCase
Aidoc Medical, Ltd. 510(k) NO: K230020(Special)
ATTN: Amalia Schreier PHONE NO : 972 73 7946870
3 Aminadav St. SE DECISION MADE: 01-FEB-23
Tel-Aviv IL 6706703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
Guangzhou Decheng Biotechnology Co510(k) NO: K230038(Traditional)
ATTN: Weifang Liu PHONE NO : 86____ 020 82557192
Room 107/218/212/405, Building 2, SE DECISION MADE: 28-FEB-23
Guangzhou CN 510000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 14F iSLEEVE™ Introducer Set
Boston Scientific Corporation 510(k) NO: K230051(Special)
ATTN: Kendall Lindenman PHONE NO : 763 4941284
One Scimed Place SE DECISION MADE: 03-FEB-23
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Flat Panel Detector
Ray Imaging Technology (Haining) L510(k) NO: K230059(Special)
ATTN: Jeffrey Wu PHONE NO : 86 0512 53690872
No. 2, Caohejing RD., Haining 3144SE DECISION MADE: 03-FEB-23
Haining CN 314499 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G Surgical Marksman Spinal Deformity System
G Surgical LLC 510(k) NO: K230063(Special)
ATTN: Donald Grafton PHONE NO : 512 4944749
9433 Bee Cave Road Building 3, SuiSE DECISION MADE: 09-FEB-23
Austin TX 78733 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Okti
Compumedics Limited 510(k) NO: K230073(Third Party - Traditional)
ATTN: John Joseph PHONE NO : 61 38420 7300
30-40 Flockhart Street SE DECISION MADE: 09-FEB-23
Abbotsford AU 3067 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ETHICON LINX® Esophagus Sizing Tool
Torax Medical Inc. 510(k) NO: K230089(Special)
ATTN: Brian Godwin PHONE NO : 513 3373623
4188 Lexington Avenue North SE DECISION MADE: 09-FEB-23
Shoreview MN 55126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ScanX Swift 2.0, ScanX Swift View 2.0
Durr Dental SE 510(k) NO: K230095(Special)
ATTN: Oliver Lange PHONE NO : 49 0_____ 7142705190
Hopfigheimer Str. 17 SE DECISION MADE: 06-FEB-23
Bietigheim-Bissingen DE 74321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bony Trauma Extremity System (BTES) Screw Range, NX Nail
Field Orthopaedics Pty Ltd 510(k) NO: K230118(Special)
ATTN: Jillianne McKenzie PHONE NO : 610 478 188591
30 Florence St SE DECISION MADE: 16-FEB-23
Teneriffe AU 4005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReShape Calibration Tubes
ReShape Lifesciences 510(k) NO: K230131(Special)
ATTN: Dov Gal PHONE NO : 949 4814789 171
1001 Calle Amanecer SE DECISION MADE: 15-FEB-23
San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Radiography CXDI-CS01
Canon, Inc. 510(k) NO: K230175(Special)
ATTN: Akira Hirai PHONE NO : 81 33758 2111
9-1 Imaikami-cho Nakahara-ku SE DECISION MADE: 15-FEB-23
Kawasaki JP 211-8501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rosa Knee System
Orthosoft, Inc (d/b/a Zimmer CAS) 510(k) NO: K230180(Special)
ATTN: Kruti Gosalia PHONE NO : 617 3090575
75 Queen St., Suite 3300 SE DECISION MADE: 22-FEB-23
Montreal CA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.via View&GO VA40A
Siemens Healthcare GmBH 510(k) NO: K230196(Third Party - Traditional)
ATTN: Frederike Jakob PHONE NO : 49 0162 1092694___
Siemensstraße 1, Forchheim SE DECISION MADE: 13-FEB-23
Erlangen DE 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BoneMRI v1.6
MRIguidance B.V. 510(k) NO: K230197(Special)
ATTN: Marijn Van Stralen PHONE NO :
Maliesingel 23 SE DECISION MADE: 22-FEB-23
Utrecht NL 3581 BG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Pre-calibrated Brain Biopsy Needle 2.0
Pajunk GmbH Medizintechnologie 510(k) NO: K230201(Special)
ATTN: Christian Quass PHONE NO : 49 770 49291586
Karl-Hall-Str. 1 SE DECISION MADE: 22-FEB-23
Geisingen DE 78187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Veloxion System
Corinth MedTech, Inc. 510(k) NO: K230205(Special)
ATTN: George Hsu PHONE NO : 408 7030722
1190 Saratoga Ave, Ste 210 SE DECISION MADE: 24-FEB-23
San Jose CA 95129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K230207(Third Party - Traditional)
ATTN: Sulgue Choi PHONE NO : 425 2819898
22010 S.E. 51st Street SE DECISION MADE: 13-FEB-23
Issaquah WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Swoop® Portable MR Imaging System™
Hyperfine, Inc. 510(k) NO: K230208(Special)
ATTN: Christine Kupchick PHONE NO : 203 3433404
351 New Whitfield St. SE DECISION MADE: 22-FEB-23
Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OrthoButton AL
Riverpoint Medical, LLC 510(k) NO: K230212(Special)
ATTN: Rebecca DeFrancia PHONE NO : 503 5178001
815 NE 25th Ave SE DECISION MADE: 23-FEB-23
Portland OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)
Stryker 510(k) NO: K230216(Special)
ATTN: Michelle Stephens PHONE NO : 904 6081262
5900 Optical Ct SE DECISION MADE: 23-FEB-23
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-Line Hernia Mesh
Deep Blue Medical Advances, Inc. 510(k) NO: K230227(Special)
ATTN: William Perry PHONE NO : 408 2429323
701 W Main Street, Suite 410 SE DECISION MADE: 23-FEB-23
Durham NC 27701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)
Iridex Corporation 510(k) NO: K230228(Special)
ATTN: Mari Iwamoto PHONE NO : 650 6058727
1212 Terra Bella Ave. SE DECISION MADE: 23-FEB-23
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Jumong General
SG Healthcare CO LTD 510(k) NO: K230241(Special)
ATTN: Byung Ju Kang PHONE NO : 82 2 4496908
10 Yongnyeong-ro, Moga-myeon IchenSE DECISION MADE: 23-FEB-23
Seoul KR 17408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System
L&K BIOMED Co., Ltd. 510(k) NO: K230245(Special)
ATTN: Katherine Kim PHONE NO : 82 10 54770325
101, 201, 202 16-25, DongbaekjungaSE DECISION MADE: 28-FEB-23
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIOLA
Vascular Graft Solutions, Ltd. 510(k) NO: K230248(Special)
ATTN: Orit Yarden PHONE NO : 972 54 3073050
24 Raoul Wallenberg Street SE DECISION MADE: 28-FEB-23
Tel-Aviv IL 6971921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M™ VitCal Liner/Base
3M ESPE Dental Products 510(k) NO: K230270(Third Party - Traditional)
ATTN: Chandrapaul Parsram PHONE NO : 651 4673014___
2510 Conway Avenue SE DECISION MADE: 06-FEB-23
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EsoCheck Cell Collection Device
Lucid Diagnostics, Inc. 510(k) NO: K230339(Special)
ATTN: Deepika Lakhani PHONE NO : 1 216 5366527
360 Madison Ave, Floor 25 SE DECISION MADE: 24-FEB-23
New York NY 10017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Alma Soprano Titanium
Alma Lasers Inc. 510(k) NO: K230371(Special)
ATTN: Jessica Rivera-Montejo PHONE NO : 224 3772000
485 Half Day Rd Ste 100 SE DECISION MADE: 22-FEB-23
Buffalo Grove IL 60089 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 251
TOTAL WITH SUMMARIES 241
TOTAL WITH STATEMENTS 10
