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
DNA/RNA Shield SafeCollect Saliva Collection kit
Zymo Research
Disposable Surgical Mask (non sterile)
Qinhuangdao Taizhi Medical Technology Co., Ltd.
GalaFLEX LITE Scaffold
Tepha, Inc.
BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Nee
Becton Dickinson Infusion Therapy Systems, Inc.
FemVue® Controlled Saline-Air Device (FSA-300)
Femasys, Inc.
Arm Blood Pressure Monitor
Alicn Medical Shenzhen, Inc.
MIRARI® Cold Plasma System ( GV-M2-01)
General Vibronics, Inc.
Quicktome Software Suite
Omniscient Neurotechnology Pty Ltd (O8t)
ONVOY Acetabular System
Globus Medical, Inc.
ALIGN Radial Head System
Skeletal Dynamics, Inc.
UltraClear Fractional Laser System
Fa International, LP
VOCO Retraction Paste
Voco GmbH
Customized Abutment
Arum Dentistry Co., Ltd.
DePuy CONDUIT LLIF SQUID Inserter
Enztec Limited
SAGICO Spinal System
Sagico VA USA, LLC
eMVFit (MVF-10M)
Weero Co., Ltd.
AITRICS-VC
Aitrics Co., Ltd.
RENASYS-WF White Foam NPWT Dressing Small; RENASYS-WF White Foam NPWT Dressing Large
Smith and Nephew Medical Limited
Elvie Stride
Chiaro Technology Limited
Air Smart Extra Spirometer
Feellife Health, Inc.
Verifine® Pen Needles
Promisemed Hangzhou Meditech Co., Ltd.
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5
Canon Medical Systems Corporation
SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
Immunalysis Corporation
Freedom® Total Knee System
Maxx Orthopedics, Inc.
Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)
Alliage S/A Industrias Médico Odontológica
ApolloKnee
Corin U.S.A. Limited
Ecomed Disposable Administration Sets
Ecomed Solutions, LLC
Accu-Chek Safe-T-Pro Plus Lancing Device
Roche Diabetes Care, Inc.
GT5 conductive & abrasive gel
Wuhan Greentek Pty , Ltd.
Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories
Alma Lasers, Inc.
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