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
Provena(TM) Midline Catheter
C.R. Bard, Inc.
3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix
Deltamed GmbH
Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ C
ArthroCare Corporation
Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)
Aveera Medical, Inc.
ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSL
Ethicon Endo-Surgery, LLC
Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
Spectrum Medical S.R.L.
Cell-Free DNA BCT
Streck, Inc.
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Reso
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Synthetic Polymer Glove - Polyethylene (Black)
Ur Industry Sdn Bhd
VOLT Proximal Humerus 3.5 Plating System
Synthes GmbH
aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar
Carlsmed, Inc.
Disposable Warming Blanket
Hangzhou Tappa Medical Technology Co., Ltd.
Luja Set
Coloplast Corp.
Virage® OCT Spinal Fixation System
Highridge Medical, LLC
CuffTrek
Shanghai Longmann Tech Co., Ltd.
Zenition 90
Philips Medical Systems Nederlands B.V.
Disposable Medical Surgical Mask
Weihai Dishang Medical Technology Co., Ltd.
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
Exceleron Medical
EL CAPITAN Anterior Lumbar Interbody Fusion System
Astura Medical
SmarTooth
Smartooth Co., Ltd.
syngo Application Software
Siemens Medical Solutions USA, Inc.
Infrared Thermometer TET-351
Truly Instrument Limited
InfaTherm Disposable Infant Warming Mattress
International Biomedical
da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc.
UNO Negative Pressure Wound Therapy System
Genadyne Biotechnologies, Inc.
Surgical Face Mask
Taiwan Comfort Champ Manufacturing Co., Ltd.
GenaCheck Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/X
Genabio Diagnostics, Inc.
TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
Ningbo Tianyi Medical Appliance Co., Ltd.
MedCAD® AccuStride System
Medcad
SofWave System
Sofwave Medical, Ltd.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert