FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79921–79944 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 2001
SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND...
K010373 · FPA
Sterling Medivations, Inc.
General Hospital · 34d
Cleared Mar 13, 2001
7230 ULTRASOUND IMAGING SYSTEM WITH TEI
K010405 · IYN
Biosound Esaote, Inc.
Radiology · 29d
Cleared Mar 13, 2001
ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349
K010428 · JJX
Beckman Coulter, Inc.
Chemistry · 28d
Cleared Mar 13, 2001
OPTETRAK B-SERIES TOTAL KNEE SYSTEM
K010434 · JWH
Exactech, Inc.
Orthopedic · 28d
Cleared Mar 13, 2001
MODIFICATION TO EBI XFIX DFS RAIL SYSTEM
K010437 · KTT
Ebi, L.P.
Orthopedic · 28d
Cleared Mar 13, 2001
ALPHA DX SYSTEM
K010562 · MMI
First Medical, Inc.
Chemistry · 15d
Cleared Mar 12, 2001
FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM
K003837 · OXO
Ge Oec Medical Systems
Radiology · 90d
Cleared Mar 12, 2001
D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM
K010082 · HQE
Dutch Ophthalmic USA, Inc.
Ophthalmic · 61d
Cleared Mar 12, 2001
PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY...
K010126 · LPL
Cl-Tinters
Ophthalmic · 55d
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