FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
79417–79440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 2001
ERO SCAN OAE TEST SYSTEM
K010165 · EWO
Etymotic Research
Ear, Nose, Throat · 53d
Cleared Mar 12, 2001
ATLAS MULTI-PURPOSE DSA SYSTEM
K010391 · IZI
Cares Built, Inc.
Radiology · 31d
Cleared Mar 12, 2001
ATHENA REMOTE CONTROLLED RF SYSTEM
K010392 · JAA
Cares Built, Inc.
Radiology · 32d
Cleared Mar 12, 2001
APOLLO MOBILE C ARM SYSTEM
K010393 · OXO
Cares Built, Inc.
Radiology · 32d
Cleared Mar 12, 2001
PHILIPS BV PULSERA/ENDURA
K010435 · OWB
Philips Medical Systems, Inc.
Radiology · 27d
Cleared Mar 12, 2001
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
K010548 · HAW
Radionics, A Division of Tyco...
Neurology · 14d
Cleared Mar 12, 2001
BD VISIDRAPE OPHTHALMIC DRAPES
K010572 · KKX
Becton, Dickinson and Co.
General Hospital · 14d
Cleared Mar 09, 2001
SONICAID FM820, SONICAID FM830
K002150 · HGM
Oxford Instruments
Obstetrics & Gynecology · 235d
Cleared Mar 09, 2001
OPD-SCAN, MODELS ARK-10000 AND ARK-9000
K003299 · HLQ
Nidek Co., Ltd.
Ophthalmic · 140d
Cleared Mar 09, 2001
CARRIAZO BARRAQUER SINGLE USE MICROKERATOME
K003594 · HMY
Moria, Inc.
Ophthalmic · 108d
Cleared Mar 09, 2001
ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM,...
K003816 · HWC
Arthrex, Inc.
Orthopedic · 88d
Cleared Mar 09, 2001
EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC...
K003867 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 87d
Cleared Mar 09, 2001
SLEEVED FILTER
K010040 · CAH
King Systems Corp.
General Hospital · 63d
Cleared Mar 09, 2001
VCF PERSONAL LUBRICANT
K010182 · NUC
Apothecus Pharmaceutical Corp.
Obstetrics & Gynecology · 49d
Cleared Mar 09, 2001
MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM
K010367 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 30d
Cleared Mar 09, 2001
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS
K010390 · DXT
Acist Medical Systems, Inc.
Cardiovascular · 28d
Cleared Mar 09, 2001
CENTURA PHOTOTHERAPY SPOTLIGHT
K010495 · LBI
Medical Illumination International, Inc.
General Hospital · 17d
Cleared Mar 09, 2001
TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY
K010505 · DPS
Brentwood Medical Technology Corp.
Cardiovascular · 16d
Cleared Mar 09, 2001
NICOLET VERSALAB
K010521 · JAF
Nicolet Biomedical
Radiology · 15d
Cleared Mar 08, 2001
PERFADEX SOLUTION FOR ORGAN PRESERVATION
K000881 · MSB
Vitrolife Sweden AB
Gastroenterology & Urology · 353d
Cleared Mar 08, 2001
PVS 1300 NEURO GUIDE WIRE
K002907 · DQX
Precision Vascular Systems, Inc.
Cardiovascular · 171d
Cleared Mar 08, 2001
LASER 3 SPSC300
K003058 · INI
Pride Mobility Products Corp.
Physical Medicine · 157d
Cleared Mar 08, 2001
LIFECARE COMPACT TENS DEVICE
K003369 · GZJ
Lifecare , Ltd.
Neurology · 129d
Cleared Mar 08, 2001
NEWTOM QR-DVT 9000
K003787 · OAS
Aperio Services, LLC
Radiology · 90d