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510(k) Device Clearances

Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.

15,000 total clearances

Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)

Adaptiiv Medical Technologies, Inc.

M.U.S.T. MINI Posterior Cervical Screws System Extension

Medacta International S.A.

Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu

B&E Korea Co., Ltd.

OsteoFlo® HydroPutty™

SurGenTec, LLC

MSFX Mikron Cervical Anterior Plate System

Mikron Makina Sanayi VE Ticaret Ltd. Sti.

NET Recovery Corp/NET Device

Net Recovery

Disposable Polypectomy Snare

Beijing Zksk Technology Co., Ltd.

Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

Perfuze, Ltd.

Arthrex Spine Compression FT Screw

Arthrex, Inc.

BIOCHARGE

Nanofiber Solutions, LLC

SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove

Showa Best Glove, Inc.

BriefCase-Quantification

Aidoc Medical , Ltd.

Bovine Dermis Collagen Dermal Matrix

Collagen Matrix, Inc.

Aevumed FASE Suture Anchor

Aevumed, Inc.

FloPatch FP120

Flosonics Medical

AI-Rad Companion Brain MR

Siemens Healthcare GmbH

T-Line Hernia Mesh

Deep Blue Medical Advances, Inc.

KLS Martin Level One Rib Fixation System

KLS-Martin L.P.

LUOFUCON® Silver Collagen Dressing

Huizhou Foryou Medical Devices Co., Ltd.

Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System

Dexcom, Inc.

ART-Plan+ (v.3.0.0)

Therapanacea Sas

CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant

Providence Medical Technology, Inc.

Disposable Safety Lancet

SteriLance Medical (Suzhou), Inc.

Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1

Byonyks Pvt, Ltd.

GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating

Waldemar Link GmbH & Co. KG

Anchor Bolts as Accessories to Depth Electrodes

Ad-Tech Medical Instrument Corporation

Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G

Shenzhen AOJ Medical Technology Co., Ltd.

INDIGO® Aspiration System – INDIGO Link

Penumbra, Inc.

Vis-U-All Low Temperature Sterilization Pouches

STERIS Corporation

Roosin Collagen Dressing

Roosin Medical Co., Ltd.

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