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.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert