| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K221266 |
01/05/2023 |
Cervical Spine Truss System (CSTS) Interbody Fusion Device |
4WEB Medical, Inc. |
Lewis Harrison |
| K213198 |
01/05/2023 |
Ax-Surgi Surgical Hemostat |
Advamedica Inc. |
Leo Mavely |
| K223719 |
01/11/2023 |
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System |
Aegis Spine, Inc. |
Kihyang Kim |
| K223521 |
01/20/2023 |
ZESPIN SI Joint Fusion System |
Aegis Spine, Inc. |
KiHyang Kim |
| K222458 |
01/12/2023 |
AIBOLIT 3D+ |
Aibolit Technologies, LLC |
Gregory Piskun |
| K223819 |
01/18/2023 |
SI-Cure Sacroiliac Joint Fusion System |
Alevio, LLC |
Trey Robbins |
| K223782 |
01/12/2023 |
Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set |
Ambu A/S |
Kristian Moltved |
| K222809 |
01/03/2023 |
Medical Disposable Face Masks |
Anqing Mayfield Medical Limited |
Minghan Zhou |
| K213597 |
01/18/2023 |
MultiCut Solo |
Asclepion Laser Technologies GmbH |
Tom Gruender |
| K223866 |
01/25/2023 |
CarevixÖ Suction Cervical Stabilizer |
Aspivix SA |
Mauro Rinaldi |
| K222889 |
01/20/2023 |
FlowArt« Needle-Free Split Septum Valve |
Asset Medikal Tasarim San Tic As. |
Ebru Sirali |
| K222554 |
01/19/2023 |
EL CAPITAN Anterior Lumbar Interbody Fusion |
Astura Medical |
Parker Kelch |
| K221125 |
01/04/2023 |
SilentCloud |
Aureliym GmBH |
Markus Haller |
| K213059 |
01/27/2023 |
Tibia and Fibula System |
Auxein Medical Private Limited |
Rahul Luthra |
| K223016 |
01/27/2023 |
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit |
BD |
Dung Nguyen |
| K223503 |
01/19/2023 |
Access 25(OH) Vitamin D Total |
Beckman Coulter Inc |
Kate Oelberg |
| K223405 |
01/13/2023 |
Access Testosterone |
Beckman Coulter, Inc. |
Kuljeet Kaur |
| K222182 |
01/04/2023 |
Radial Artery Compression Tourniquets |
Beijing Demax Medical Technology Co., Ltd. |
Anny Zhang |
| K220803 |
01/27/2023 |
VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 ╡g/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 ╡g/mL), VITEK 2 AST-GP Moxifloxacin |
bioMerieux, Inc |
Cherece L. Jones |
| K223644 |
01/12/2023 |
Neuronaute with IceCap 2 & IceCap 2 Small |
Bioserenity |
Madubuike Okafor |
| K221542 |
01/13/2023 |
Galileo Vertebral Body Replacement Device |
Bright Spine |
Robert Simonson |
| K223177 |
01/20/2023 |
HighlanderÖ 014 PTA Balloon Dilatation Catheter |
C.R. Bard, Inc. |
Andrew Quach |
| K223336 |
01/09/2023 |
Vitrea Software Package, VSTP-002A |
Canon Medical Systems Corporation |
Paul Biggins |
| K221260 |
01/06/2023 |
CSF-3 |
CardiacSense |
Benita Lanzer |
| K223842 |
01/20/2023 |
DRX - Compass |
Carestream Health, Inc. |
Jessica DeRyke |
| K223794 |
01/17/2023 |
hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS |
CEFLA S.C. |
Lorenzo Bortolotti |
| K211197 |
01/19/2023 |
Disposable Endoscopic Cutter Stapler and Cartridge |
Changzhou Waston Medical Appliance Co., Ltd |
Ning Mao |
| K222787 |
01/09/2023 |
Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P |
Chongqing Sunkingdom Medical Instrument Co., Ltd |
Shulin Guo |
| K222593 |
01/18/2023 |
TruPlan Computed Tomography (CT) Imaging Software |
Circle Cardiovascular Imaging, Inc. |
Sydney Toutant |
| K222406 |
01/23/2023 |
Clarius AI |
Clarius Mobile Health Corp. |
Agatha Szeliga |
| K223738 |
01/11/2023 |
Alpha Control Liner System (ACLS) |
Coapt |
Blair Lock |
| K223563 |
01/25/2023 |
OsteoCNX |
Converg Engineering |
Gustavo R Prado |
| K223158 |
01/23/2023 |
LigaSureÖ XP Maryland Jaw Sealer/Divider |
Covidien, llc |
Miranda Miles |
| K223200 |
01/06/2023 |
Curiteva Navigation System |
Curiteva, Inc. |
Eric Linder |
| K221494 |
01/23/2023 |
Quality Mix Blender, Oxymixer |
DEHAS Medical Systems GmbH |
Jens Mittendorf |
| K191111 |
01/11/2023 |
DD Solid Connect« CAD/CAM Abutments |
Dental Direkt GmbH |
Gerhard de Boer |
| K222976 |
01/12/2023 |
MU System |
Dentis Co., Ltd |
Gyu Ri Kim |
| K222913 |
01/13/2023 |
s-Clean Link Abutment |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K222296 |
01/06/2023 |
ARTICUL/EZE Ceramic Heads |
Depuy Ireland UC |
Paige Myers |
| K223931 |
01/11/2023 |
Dexcom G6 Continuous Glucose Monitoring (CGM) System |
Dexcom, Inc. |
Brittney Shaver |
| K221150 |
01/25/2023 |
Advanced Bone Plate |
Double Medical Technology Inc. |
Yan Zuo |
| K221088 |
01/18/2023 |
Anatomic Bone Plate |
Double Medical Technology Inc. |
Yan Zuo |
| K221090 |
01/10/2023 |
Metal Cannulated Screw |
Double Medical Technology Inc. |
Yan Zuo |
| K220073 |
01/26/2023 |
RMF-2000 |
DRTECH Corporation |
Suyeon Back |
| K223221 |
01/13/2023 |
Non-Sterile Powder Free Nitrile Examination Gloves |
Dynacare Sdn Bhd |
Chow Choong Keong |
| K222221 |
01/04/2023 |
DEKA HELIX |
El.En Electronic Engineering Spa |
Paolo Peruzzi |
| K222832 |
01/21/2023 |
Sentimag System |
Endomagnetics Ltd |
Mehryar Behizad |
| K221873 |
01/12/2023 |
NeoGen PSR System |
Energist Limited |
Graham Booth |
| K223671 |
01/05/2023 |
CONDUIT LLIF Straight Inserters |
Enztec Limited |
James Sheat |
| K213423 |
01/06/2023 |
T3 Platform software |
Etiometry. Inc. |
Tim Hanson |
| K221338 |
01/27/2023 |
F&P Airvo 3 |
Fisher & Paykel Healthcare |
Reena Daken |
| K223540 |
01/19/2023 |
AvalancheLase Family |
Fotona d.o.o. |
Tina Bartolic |
| K223295 |
01/11/2023 |
Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D |
FUJIFILM Corporaton |
Randy Vader |
| K221551 |
01/27/2023 |
FUJIFILM Endoscope Model EI-740D/S |
FUJIFILM Corporaton |
Randy Vader |
| K221619 |
01/26/2023 |
ECHELON Oval V6.2 MRI System |
Fujifilm Healthcare Corporation |
Randy Vader |
| K221774 |
01/12/2023 |
Garmin ECG App |
Garmin International, Inc. |
Travis Johnson |
| K223378 |
01/03/2023 |
3.0T 16ch AIR AA |
GE Healthcare Coils (USA Instruments, Inc.) |
Lauren Ross |
| K223847 |
01/25/2023 |
CREEDÖ Cannulated Screws |
GLW, Inc. |
Arundhati Radhakrishnan |
| K221419 |
01/20/2023 |
TD-5010 Lancing Device and TD-5084 Sterile Lancets |
GOSTAR Co., Ltd. |
Pei-Fen Yang |
| K214077 |
01/20/2023 |
Digital Thermometer, Model: DT007, DT008 |
Guangzhou Berrcom Medical Device Co., Ltd. |
Zhigang Du |
| K222403 |
01/26/2023 |
Surgical Gown |
Guangzhou Fuzelong Hygiene Material Co., Ltd |
Yuehua Zhou |
| K221306 |
01/27/2023 |
SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories |
Gyrus ACMI, Inc. |
Jon Gilber |
| K222170 |
01/13/2023 |
Power Acute Triple Lumen Hemodialysis Catheter |
Health Line International Corporation |
Aaron G Faulkner |
| K213655 |
01/17/2023 |
HiTop« (Models: HiToP«4touch, HiToP«2touch, HiToP«1touch) |
HillTek LLC |
Mohammadali Nezakati |
| K214078 |
01/13/2023 |
SilkÆn Toothwave |
Home Skinovations Ltd. |
Amit Goren |
| K221278 |
01/11/2023 |
Transducer Probe Cover |
Hony Medical Co., Ltd. |
Zhu Huina |
| K223528 |
01/20/2023 |
Triathlon« Hinge Knee System |
Howmedica Osteonics Corp. dba Stryker Orthopaedics |
Allison Byrne |
| K222056 |
01/26/2023 |
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee |
Howmedica Osteonics Corp., dba Stryker Orthopaedics |
Margaret Klippel |
| K223314 |
01/25/2023 |
Disposable Blood Lancets |
HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD |
Zhengcan Da |
| K223313 |
01/23/2023 |
Disposable Safety Lancets |
HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD |
Zhengcan Da |
| K222483 |
01/04/2023 |
Surgical Face Mask |
Hubei Woozon Healthcare Co.,Ltd. |
Li Chunlin |
| K222011 |
01/12/2023 |
HandX Instrument - Monopolar Spatula |
Human Xtensions Ltd. |
Maija Wallenstein |
| K222181 |
01/11/2023 |
Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate |
Iconic medicare sdn bhd |
Tan Cho Chia |
| K222789 |
01/09/2023 |
VADER« Pedicle System, G21 Cement |
icotec ag |
Marina Hess |
| K213263 |
01/04/2023 |
OnyxCeph |
Image Instruments GmbH |
Greg Holland |
| K223000 |
01/11/2023 |
Artix BG |
Inari Medical |
Ellen Nguyen |
| K223254 |
01/27/2023 |
C2 Xplore |
Inomed Medizintechnik GmbH |
Maximilian Wimmer |
| K223090 |
01/27/2023 |
GEM Premier ChemSTAT |
Instrumentation Laboratory Co |
Gabriella Erdosy |
| K222589 |
01/26/2023 |
Flexible Suturing System with Anchors (FSSA) |
Integrity Orthopaedics, Inc. |
Jeff Sims |
| K223010 |
01/17/2023 |
Portable X-ray System |
iRay Technology Taicang Ltd. |
Wei Pan |
| K223675 |
01/06/2023 |
WatchPAT ONE (WP1) |
Itamar Medical, LTD |
Efrat Litman |
| K222462 |
01/20/2023 |
Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-au |
ITP Innovative Tomography Products GmbH |
Dr. Heinz-Werner Henke |
| K223685 |
01/04/2023 |
SmoothCool HR System |
Jeisys Medical Inc |
Sang Hoon Hwang |
| K222834 |
01/05/2023 |
Safety Push Button Blood Collection Set |
Jiangsu Caina Medical Co.,Ltd |
Jianwei Pan |
| K221682 |
01/13/2023 |
Ideal Med Pro 3-Ply Disposable Face Mask |
JSN Holdings, LLC |
Brian Tedesco |
| K222158 |
01/20/2023 |
Capiflo 5001 |
K&L Distributing, Inc. |
Mark Julian |
| K222830 |
01/12/2023 |
Rainbow 360 |
Kerr Corporation |
Viviana Lai |
| K223927 |
01/27/2023 |
360CAS |
Kico Knee Innovation Company Pty Limited |
Danyon Munro |
| K223749 |
01/06/2023 |
U by Kotex« Click« Unscented Menstrual Tampons |
Kimberly-Clark Corporation |
Jeremy Paulsen |
| K223474 |
01/13/2023 |
PathLoc-TA Expandable Lumbar Cage System |
L&K Biomed Co., Ltd. |
Katherine Kim |
| K223588 |
01/26/2023 |
PALLAS Premium |
Laseroptek Co., Ltd. |
Hong Chu |
| K223546 |
01/27/2023 |
14HQ721G-B |
LG Electronics Inc. |
Jinhwan Jun |
| K223789 |
01/09/2023 |
21HQ513D |
LG Electronics Inc. |
Jinhwan Jun |
| K213772 |
01/19/2023 |
LM-9300 Plus Lithotripter |
Lite-Med Inc. |
Walt Hsu |
| K222171 |
01/13/2023 |
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ |
Magstim Company Ltd |
Tom Campbell |
| K223415 |
01/26/2023 |
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
Mah Sing Healthcare Sdn Bhd |
Ivan Tan Chee Wei |
| K221725 |
01/20/2023 |
Advanced MyHip Planner |
Medacta International S.A. |
Stefano Baj |
| K223795 |
01/17/2023 |
FairFix QT Adjustable Button |
Medacta International S.A. |
Stefano Baj |
| K223548 |
01/20/2023 |
GMK Sphere & GMK SpheriKA Cementless |
Medacta International S.A. |
Stefano Baj |
| K223166 |
01/19/2023 |
Medaica M1 Telehealth Stethoscope |
Medaica Inc. |
Stephen Randall |
| K212684 |
01/28/2023 |
BrainView QEEG Software |
Medeia, Inc. |
Slav Danev |
| K211559 |
01/27/2023 |
EasyStat 300 |
Medica Corporation |
Photios Makris |
| K222000 |
01/18/2023 |
Transit-Pellets |
Medifactia AB |
Diana Nystrom |
| K223480 |
01/13/2023 |
Medipoint Blood Lancets |
Medipoint Holdings, LLC |
Rochelle Stern |
| K210166 |
01/27/2023 |
Omnispec ED1000 |
Medispec Ltd. |
Avner Spector |
| K222665 |
01/25/2023 |
Medline UNITE« Ankle Fusion Plating System |
Medline Industries, Inc. |
Jennifer Mason |
| K223108 |
01/19/2023 |
TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) |
Medos International, SARL |
Karin McDonough |
| K223494 |
01/23/2023 |
CD Horizon Spinal System |
Medtronic |
Madhuvanthi Soundirarajan |
| K223764 |
01/11/2023 |
INFINITY OCT System |
Medtronic Sofamor Danek USA, Inc. |
Laura Beth Parr |
| K211812 |
01/06/2023 |
BLUEDIAMOND IMPLANT, Abutment Screw |
MegaGen Implant Co., Ltd. |
Hyo Eun Lee |
| K222779 |
01/26/2023 |
Revogene |
Meridian Bioscience, Inc |
Jack Rogers |
| K223872 |
01/19/2023 |
Low Profile Companion Sheath |
Merit Medical Systems, Inc. |
Kirk McIntosh |
| K222115 |
01/10/2023 |
ISAAC Neurovascular Navigation Catheter |
MicroVention, Inc. |
Sona Manickam |
| K223800 |
01/17/2023 |
MIM û Additional Tracers |
MIM Software Inc. |
Megan Fontanez |
| K223107 |
01/18/2023 |
MOLLI 2 |
MOLLI Surgical, Inc |
Joseph De Croos |
| K223351 |
01/31/2023 |
Naviswiss Knee |
Naviswiss AG |
Domenico Romeo |
| K223222 |
01/17/2023 |
Plasma IQ |
Neauvia North America, Inc |
Joy Willard |
| K221424 |
01/26/2023 |
Sterile Surgical Powder Free Latex Glove |
New Era Medicare Sdn. Bhd. |
Fatin Nor Irdina binti Ahmad Fauzi |
| K213175 |
01/19/2023 |
No Stress Impress |
No Stress Impress LLC |
Misael Otero |
| K223731 |
01/12/2023 |
NuVasive Modulus-C Interbody System |
Nuvasive, Inc. |
Meet Vaghani |
| K223181 |
01/11/2023 |
NuVasive Reline System |
NuVasive, Incorporated |
Bland Tanesha |
| K223502 |
01/13/2023 |
MR Diffusion Perfusion Mismatch V1.0 |
Olea Medical |
Nathalie Palumbo |
| K221683 |
01/20/2023 |
CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) |
Olympus Medical Systems Corporation |
Shinichiro Kawachi |
| K221522 |
01/19/2023 |
HF-cables (resusable) |
Olympus Winter & Ibe Gmbh |
Lilly Omland |
| K223183 |
01/13/2023 |
Light-Guide Cables |
Olympus Winter & Ibe GmbH |
Ali Sayad |
| K223348 |
01/30/2023 |
My3D« Personalized Pelvic Reconstruction |
Onkos Surgical, Inc. |
Matthew Vernak |
| K222799 |
01/10/2023 |
Haymaker« Screw System |
OrthoCircle Spine d.b.a. OC Medical Devices |
Jack Matthews |
| K221933 |
01/13/2023 |
MONTAGE Settable, Resorbable Bone Putty |
Orthocon, Inc. |
Aniq Darr |
| K223118 |
01/21/2023 |
OIC Variable Angle Small Fragment Locking Plate System |
Orthopaedic Implant Company |
Douglas Fulton |
| K223650 |
01/05/2023 |
REMEDY Stemmed Knee Spacer |
OsteoRemedies, LLC |
Eric Stookey |
| K222901 |
01/27/2023 |
EVA15 insufflator |
Palliare Ltd. |
John O'Dea |
| K221949 |
01/26/2023 |
Ortho Device, ADAPTIX 3D Orthopedic Imaging System |
Pausch Medical GmbH |
Christian Stoian |
| K222848 |
01/20/2023 |
pRESET Thrombectomy Device |
phenox Limited |
Catriona Lynch |
| K223804 |
01/18/2023 |
PercuNav Image Fusion and Interventional Navigation System |
Philips Ultrasound LLC |
Courtney Nix |
| K203792 |
01/20/2023 |
Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle |
Pikdare S.p.A |
Roberta Zanoni |
| K222567 |
01/30/2023 |
Playground For All Love Sesh |
Playground For All |
Sandy Vukovic |
| K210112 |
01/30/2023 |
XChange Device, XChange System |
Pneuma Therapeutics, Inc. |
William Densel |
| K221020 |
01/13/2023 |
Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F |
Potrero Medical, Inc. |
Priscila Tapia |
| K222150 |
01/12/2023 |
PreXion3D Expedition |
PreXion Corporation |
Hiroaki Takahashi |
| K223429 |
01/13/2023 |
Contour Knee |
Quality Electrodynamics, LLC |
Eric Yeh |
| K221868 |
01/27/2023 |
QOCA image Smart CXR Image Processing System |
Quanta Computer Inc. |
Joe Wang |
| K223404 |
01/20/2023 |
Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V |
Quanta System, S.p.A. |
Dario Bandiera |
| K223465 |
01/11/2023 |
RadianceTx Radionuclide Brachytherapy Source |
Radiance Therapeutics Inc. |
Laurence Marsteller |
| K220649 |
01/17/2023 |
Elucis |
Realize Medical Inc. |
Dan La Russa |
| K222907 |
01/04/2023 |
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate |
RMKH Glove (Cambodia) Co., Ltd. |
Yang Clement KC |
| K221693 |
01/04/2023 |
Elecsys Anti-HCV II (08837031190) |
Roche Diagnostics |
Bin Sun |
| K222801 |
01/25/2023 |
Safety Lancet |
Sarstedt AG & CO KG |
Jochen Hoffman |
| K222437 |
01/26/2023 |
Aristotle Colossus Guidewire |
Scientia Vascular Inc |
Max Alfonso |
| K221252 |
01/13/2023 |
Scivita 4KINSIGHT ICG Imaging System |
Scivita Medical Technology Co., Ltd. |
Ruqin Wu |
| K211759 |
01/18/2023 |
Selux AST System; Model AST Gen 1.0 |
Selux Diagnostics, Inc. |
Eric Stern |
| K223903 |
01/27/2023 |
Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105) |
Semperit Investments Asia PTE LTD. |
Alexander Weinert |
| K203380 |
01/06/2023 |
Disposable Surgical Face Mask |
Shandong Pop Jeans Intelligent Manufacturing Co., Ltd. |
Wang Jing |
| K203833 |
01/27/2023 |
Tacrolimus Assay Kit |
Shanghai Genext Medical Technology Co., Ltd. |
Kimmy Zong |
| K220059 |
01/19/2023 |
BiosciÖ Inactivated Transport Medium, BiosciÖ ITM |
Shenzhen Dakewe Bio-engineering Co., Ltd. |
Wei Jiang |
| K220448 |
01/19/2023 |
Disposable Non-invasive EEG Sensor |
Shenzhen Med-link Electronics Tech Co., Ltd. |
Yi Liu |
| K222252 |
01/19/2023 |
Self-adhesive Electrode |
Shenzhen Roundwhale Technology Co., Ltd. |
Zeng Chunming |
| K222045 |
01/04/2023 |
Wearable Breast Pump (Model S1DW) |
Shenzhen TPH Technology Co.,Ltd. |
Peter Chen |
| K221317 |
01/13/2023 |
S-Mono |
Shinhung MST Co., Ltd. |
Sun Ho Lee |
| K223363 |
01/12/2023 |
MAMMOVISTA B.smart (VB70) |
Siemens Medical Solutions USA Inc. |
Denise Adams |
| K223635 |
01/04/2023 |
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer |
Sienco, Inc. |
Jennifer Aiken |
| K220495 |
01/13/2023 |
SignaSure Dual Mobility System |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K223446 |
01/18/2023 |
eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) |
Signifier Medical Technologies Ltd |
Yasser Zayni |
| K222664 |
01/27/2023 |
Sim&Size |
Sim&Cure |
Colette Maurin |
| K220847 |
01/03/2023 |
AETOS Shoulder System |
Smith & Nephew, Inc. |
Cassidy Lemkau |
| K220884 |
01/17/2023 |
Disposable Endoscope Valve Sets |
SML Med-Tech Solutions Limited |
Mark Ko |
| K223775 |
01/03/2023 |
EZ-STIK Electrodes |
South Dakota Partners |
Mike Plunkett |
| K213514 |
01/13/2023 |
Spectricept Skin and Wound Cleanser |
Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. |
Hoji Alimi |
| K223306 |
01/25/2023 |
SPRINT Peripheral Nerve Stimulation (PNS) System |
SPR Therapeutics, Inc. |
Kathryn Stager |
| K222818 |
01/24/2023 |
Xpedition Ö Powered Stair Chair (625700000000) |
Stryker Medical |
Rachel Stallworth |
| K222711 |
01/09/2023 |
HS186B Scooter |
Suzhou Master Machinery Manufacturing Co.,Ltd. |
Siqi Shangguan |
| K222577 |
01/06/2023 |
TECHFIT Diagnostic Models |
TECHFIT Digital Surgery Inc. |
David Garcia-Patino |
| K211163 |
01/09/2023 |
Bone Cement Genta, Bone Cement HV, Bone Cement LV |
Tecres S.p.A. |
Massimo Grazioli |
| K221899 |
01/20/2023 |
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml |
Thermo Fisher Scientific |
Cynthia Knapp |
| K203689 |
01/23/2023 |
Tidepool Loop |
Tidepool Project |
Howard Look |
| K222510 |
01/20/2023 |
Blueprint Mixed Reality system |
Tornier SAS |
Moyees Kamara |
| K221163 |
01/19/2023 |
Tunnel Crossing Catheter |
Tractus Vascular, LLC |
Janet Burpee |
| K221181 |
01/05/2023 |
Treace Medical Concepts (TMC) Plating System |
Treace Medical Concepts Inc. |
Melissa Coloroso |
| K221149 |
01/05/2023 |
U-Motion II Acetabular System-Extension line |
United Orthopedic Corporation |
Lois Ho |
| K222531 |
01/22/2023 |
Synthetic Polymer Glove - Polyethylene (Black) |
UR Industry SDN BHD |
Chua Song Han |
| K223748 |
01/13/2023 |
Nitrile Exam Gloves (Chemotherapy Drug Tested) |
US Medical Glove Company LLC |
Jorge A. Alcazar |
| K222941 |
01/17/2023 |
Halcyon, Ethos Radiotherapy System |
Varian Medical Systems, Inc |
Peter J. Coronado |
| K220114 |
01/25/2023 |
PowerPAK Syringe |
Vault Paragon Group, Inc. |
Sari Luciano |
| K223031 |
01/13/2023 |
Vibrant System |
Vibrant Ltd. |
Martha Bezalel |
| K223117 |
01/31/2023 |
V-SPERM WASH |
Vitromed GmbH |
Greg Holland |
| K223516 |
01/21/2023 |
VX1+ |
Volta Medical |
Paola Milpied |
| K223412 |
01/06/2023 |
LumiVyÖ Lumbar IBF System |
Vy Spine, LLC |
Jordan Hendrickson |
| K221754 |
01/17/2023 |
Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) |
Winner Medical Co., Ltd. |
Zhiqin Liang |
| K221755 |
01/13/2023 |
Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing |
Winner Medical Co., Ltd. |
Zhiqin Liang |
| K221532 |
01/30/2023 |
PHMB Wound Dressing |
Winner Medical Co., Ltd. |
Yi Fu |
| K221379 |
01/04/2023 |
Steriking LT-Blueline Pouches with Tyvek |
Wipak OY |
Hanna Marttila |
| K222835 |
01/27/2023 |
Prophecy Preoperative Navigation Alignment System |
Wright Medical Technology, Inc. |
Paxia Her |
| K222879 |
01/24/2023 |
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) |
Wuxi Jiajian Medical Instrument Co., Ltd |
Wu Zhifang |
| K221200 |
01/31/2023 |
XBody Go USA, XBody Pro USA |
XBody Hungary Kft. |
Orsolya Balog |
| K223411 |
01/04/2023 |
Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) |
Xiamen Probtain Medical Techology Co., Ltd |
Jianli Kang |
| K223250 |
01/19/2023 |
Disposable Nitrile Examination Glove |
Yangzhou Saraguard Medical Supplies Co.,Ltd. |
Guo Hua |
| K221627 |
01/19/2023 |
PerfusionGo Plus |
Yukun (Beijing) Technology Co., Ltd. |
Qi Wang |
| K221726 |
01/18/2023 |
Uni-FuZe-C Bone Strip |
Zavation Medical Products, LLC |
Elke Carter |
| K222782 |
01/13/2023 |
Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S) |
Zhejiang Carebao Co., Ltd. |
Xie Yan |
| K211047 |
01/10/2023 |
CoCr Head |
Zimmer GmbH |
Roberto Tommasini |
| K223746 |
01/13/2023 |
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console |
Zoll Circulation, Inc. |
Brian Robey |
