Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
32185–32208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 2016
FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1,...
K160922 · MXZ
Dako North America, Inc.
Pathology · 29d
Cleared May 02, 2016
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
K151390 · LZC
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 342d
Cleared May 02, 2016
BTI Dental Implant System UnicCa
K151391 · DZE
B.T.I. Biotechnology Institute, Sl.
Dental · 342d
Cleared May 02, 2016
HEX tanning booth
K152336 · LEJ
J & B Products Ltd Dba Hex Tanning
General & Plastic Surgery · 257d
Cleared May 02, 2016
Green Laser Photocoagulator GYC-500
K152603 · HQF
Nidek Co., Ltd.
Ophthalmic · 234d
Cleared May 02, 2016
Standard Clamp
K153358 · GDJ
Standard Bariatrics
General & Plastic Surgery · 164d
Cleared May 02, 2016
AirFit N20
K153673 · BZD
Resmed, Ltd.
Anesthesiology · 133d
Cleared May 02, 2016
Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider
K153745 · NUJ
Surgical Instrument Service and...
General & Plastic Surgery · 125d
Cleared May 02, 2016
MX50T(MX50TQS)
K160354 · PGY
Wide Corporation
Radiology · 84d
Cleared May 02, 2016
TRINITY
K160357 · IYN
Koelis
Radiology · 84d
Cleared May 02, 2016
AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR...
K160609 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 60d
Cleared May 01, 2016
EndoFLIP
K160725 · FFX
Crospon, Ltd.
Gastroenterology & Urology · 46d
Cleared May 01, 2016
EsophyX® Z Device with SerosaFuse Fasteners and Accessories
K160960 · ODE
Endogastric Solutions, Inc.
Gastroenterology & Urology · 26d
Cleared Apr 29, 2016
Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with...
K152084 · LPH
Corentec Co., Ltd.
Orthopedic · 277d
Cleared Apr 29, 2016
Rectangular Multiplace Hyperbaric Chamber System Product Family with...
K152223 · CBF
Oxyheal Medical Systems, Inc.
Anesthesiology · 266d
Cleared Apr 29, 2016
TBS iNsight
K152299 · KGI
Medimaps Group SA
Radiology · 260d
Cleared Apr 29, 2016
T-32
K152412 · LEJ
Tanses Technologies, Inc.
General & Plastic Surgery · 247d
Cleared Apr 29, 2016
Patient Monitor
K152552 · MHX
Edan Instruments, Inc.
Cardiovascular · 234d
Cleared Apr 29, 2016
Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)
K152619 · GCJ
Prosurg, Inc.
General & Plastic Surgery · 228d
Cleared Apr 29, 2016
da Vinci Xi Surgical System
K152892 · NAY
Intuitive Surgical
General & Plastic Surgery · 212d
Cleared Apr 29, 2016
REVIVAL(TM) Modular Revision Hip Stem
K152903 · LZO
Corin USA
Orthopedic · 211d
Cleared Apr 29, 2016
Dyna-Vision Telemonitoring System
K152973 · MHX
Techmedic Development International B.V.
Cardiovascular · 204d
Cleared Apr 29, 2016
Mobius3D
K153014 · IYE
Mobius Medical Systems, LP
Radiology · 197d
Cleared Apr 29, 2016
Blue Sky Bio Zygomatic Implant System
K153064 · DZE
Blue Sky Bio, LLC
Dental · 190d