510(k) Device Clearances

VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-G

bioMerieux, Inc.

Cyware 4H and Cysart 4H

Abys Medical

PeekMed web (v1)

Peek Health, S.A.

CO2 Laser System

Smedtrum Medical Technology Co., Ltd.

Breast Implant Removal Device (BIRD)

Gaylord Solutions, LLC

Safety Blood Collection Needle (Without Needle Holder)

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

XSense Cryoablation System with CryoProbes

IceCure Medical , Ltd.

Diode laser therapy device

Triangel Rsd Limited

ARIES Anterior Cervical Plate Systems

ZheJiang Decans Medical Devices Co., Ltd.

SpaceOAR Vue System (SV-2101)

Boston Scientific Corporation

Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)

Shenzhen Root Innovation Technology Co., Ltd.

Broadway 8 Catheter

Stryker Neurovascular

SIGNA Prime

Ge Healthcare (Tianjin) Company Limited

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid a

Hartalega NGC Sdn. Bhd.

TRON

Xoran Technologies, LLC

Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts

Edwards Lifesciences

Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fu

Spinal Simplicity, LLC

Tympanostomy Tubes

Grace Medical, Inc.

Powered Wheelchair (NXN20-209)

Zhejiang Nysin Medical Co., Ltd.

EffortMed PEEK Cages & Corpectomy Cages

Effortmed, LLC

Neurolyser XR (NXR100)

Fusmobile, Inc.

Dental Cone; Dental Sponge

Medizin Produkte Neustadt GmbH (Mpn)

TECHFIT Patient-Specific Cranial System

Techfit Digital Surgery, Inc.

MPO Knee Instruments; MPO PROPHECY Knee Instruments

Microport Orthopedics, Inc.

YJ-K1K2 Wheelchair (YJ-013F)

Zhenjiang Assure Medical Equipment Co., Ltd.

Atrauman® Ag

Hartmann USA, Inc.

Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)

Taidoc Technology Corporation

VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync B

Vivachek Biotech (Hangzhou) Co., Ltd.

HS Fiber Cerclage

Riverpoint Medical, LLC

Hygienic Protective Bite Cover (2207-010-50)

Dürr Dental SE