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
88705–88728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 1998
WIELISA ANCA SCREENING KIT TEST SYSTEM
K981748 · MOB
Wieslab AB
Immunology · 65d
Cleared Jul 22, 1998
WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM
K981750 · MOB
Wieslab AB
Immunology · 65d
Cleared Jul 22, 1998
PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598
K981760 · HEB
Playtime Products, Inc.
Obstetrics & Gynecology · 64d
Cleared Jul 22, 1998
CREA
K981799 · CGX
Abbott Laboratories
Chemistry · 62d
Cleared Jul 22, 1998
ALBP
K981814 · CJW
Abbott Laboratories
Chemistry · 61d
Cleared Jul 22, 1998
AMM
K981920 · JIF
Abbott Laboratories
Chemistry · 51d
Cleared Jul 22, 1998
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
K981926 · DLJ
Emd Chemicals, Inc.
Toxicology · 50d
Cleared Jul 22, 1998
DBIL
K981943 · CIG
Abbott Laboratories
Chemistry · 49d
Cleared Jul 22, 1998
AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR
K981978 · MRR
Pointe Scientific, Inc.,
Chemistry · 47d
Cleared Jul 22, 1998
TRUBYTE DENTURE BOND DENTURE BONDING AGENT
K982007 · KLE
Dentsply Intl.
Dental · 44d
Cleared Jul 22, 1998
VERABOND 2
K982094 · EJH
Aalba Dent, Inc.
Dental · 37d
Cleared Jul 22, 1998
MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
K982277 · CHL
Nova Biomedical Corp.
Chemistry · 23d
Cleared Jul 22, 1998
CHEM-CHEX STAT (NEW)
K982290 · JJY
Streck Laboratories, Inc.
Chemistry · 23d
Cleared Jul 21, 1998
LAPARO-TENSER
K970712 · HET
L & T S.N.C. DI E. Lucini & C.
Obstetrics & Gynecology · 510d
Cleared Jul 21, 1998
MODEL 02 OXYGEN ANALYZER
K971084 · CCL
Oxigraf, Inc.
Anesthesiology · 483d
Cleared Jul 21, 1998
ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM
K974200 · BZM
Orca Diagnostics Corp.
Anesthesiology · 253d
Cleared Jul 21, 1998
ITI STENT
K980290 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 176d
Cleared Jul 21, 1998
EPILASER NORMAL MODE RUBY LASER
K980517 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 161d
Cleared Jul 21, 1998
MPS HUBER NEEDLE EXTENSION SET
K982047 · FPA
Medical Product Specialists
General Hospital · 41d
Cleared Jul 21, 1998
CONTRAST CONTROL DEVICE
K982123 · FPA
Medex, Inc.
General Hospital · 35d
Cleared Jul 21, 1998
WALLSTENT ENDOPROSTHESIS
K982184 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 29d
Cleared Jul 20, 1998
WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES
K980302 · HIH
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 174d
Cleared Jul 20, 1998
PRO VISION
K980648 · LLZ
Algotec Systems, Ltd.
Radiology · 151d
Cleared Jul 20, 1998
BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT
K981029 · MOB
The Binding Site, Ltd.
Immunology · 123d