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
89209–89232 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 1998
ETEST VANCOMYCIN
K980348 · JWY
Ab Biodisk
Microbiology · 121d
Cleared May 29, 1998
DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH...
K980780 · DSP
Datascope Corp.
Cardiovascular · 88d
Cleared May 29, 1998
J-FX BIPOLAR HEAD
K980801 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 88d
Cleared May 29, 1998
BABYTHERM 8000 LDR
K980886 · FMZ
Draeger Medical, Inc.
General Hospital · 81d
Cleared May 29, 1998
IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES
K980994 · FPA
Venetec Intl., Inc.
General Hospital · 73d
Cleared May 29, 1998
PEDIATRIC PRC
K981113 · MNH
Acromed Corp.
Orthopedic · 63d
Cleared May 29, 1998
OSTEOLOCK ACETABULAR CUP
K981201 · LZO
Howmedica Corp.
Orthopedic · 57d
Cleared May 29, 1998
CREATININE (CREA)
K981240 · CGX
Abbott Laboratories
Chemistry · 53d
Cleared May 29, 1998
GEEN MEDISOX
K981296 · DWL
Geen Healthcare, Inc.
General Hospital · 50d
Cleared May 29, 1998
MICRO-STRIP FOR COCAINE METABOLITES
K981388 · DIO
Microdiagnostics, Inc.
Toxicology · 43d
Cleared May 29, 1998
DISPOSABLE RE-NEW FORCEPS
K981389 · GEI
Microline Pentax, Inc.
General & Plastic Surgery · 43d
Cleared May 29, 1998
UROSURGE SPIRASTENT PLUS URETERAL STENT
K981489 · FAD
Urosurge, Inc.
Gastroenterology & Urology · 32d
Cleared May 29, 1998
UROSURGE FILASTENT URETERAL STENT
K981491 · FAD
Urosurge, Inc.
Gastroenterology & Urology · 32d
Cleared May 29, 1998
VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM
K981700 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 15d
Cleared May 28, 1998
SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496
K972502 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 329d
Cleared May 28, 1998
ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)
K972849 · FXX
Cypress Medical Products, Ltd.
General Hospital · 300d
Cleared May 28, 1998
PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001,...
K974285 · DPW
Perimed, Inc.
Cardiovascular · 195d
Cleared May 28, 1998
ETEST OFLOXACIN
K980338 · JWY
Ab Biodisk
Microbiology · 120d
Cleared May 28, 1998
SURGISIS
K980431 · FTM
Cook Biotech, Inc.
General & Plastic Surgery · 113d
Cleared May 28, 1998
PAINBUSTER INFUSION SYSTEM
K980558 · MEB
I-Flow Corp.
General Hospital · 104d
Cleared May 28, 1998
LYSONIX LIPOPLASTY ACCESS PORT
K980763 · QPB
Lysonix, Inc.
General & Plastic Surgery · 90d
Cleared May 28, 1998
CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01,...
K980961 · DRF
Cordis Webster, Inc.
Cardiovascular · 73d
Cleared May 28, 1998
IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES
K980992 · FPA
Venetec Intl., Inc.
General Hospital · 72d
Cleared May 28, 1998
AIA-PACK MYOGLOBIN ASSAY
K981012 · DDR
Tosoh Medics, Inc.
Immunology · 71d