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
89497–89520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 1998
SOPRANO CRYO-THERAPY SYSTEM
K980393 · GEI
Gynecare Innovation Center
General & Plastic Surgery · 88d
Cleared May 01, 1998
KERATOME BLADE, CHIROM MODEL ALK 500500
K980508 · HNO
Micro Specialties, Inc.
Ophthalmic · 80d
Cleared May 01, 1998
KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200...
K980510 · HNO
Micro Specialties, Inc.
Ophthalmic · 80d
Cleared May 01, 1998
EBNA-1 IGM ELISA TEST SYSTEM
K980598 · LLM
Clark Laboratories, Inc.
Microbiology · 73d
Cleared May 01, 1998
ENDOSOLV E
K980633 · KIF
Specialites Septodont
Dental · 71d
Cleared May 01, 1998
HEELBO WAIST AND CHEST VEST
K980640 · FMQ
Heelbo, Inc.
General Hospital · 71d
Cleared May 01, 1998
REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8
K980650 · JHO
Helena Laboratories
Chemistry · 71d
Cleared May 01, 1998
CERA E DENTAL ALLOY
K980661 · EJS
European Dental Imports, Inc.
Dental · 70d
Cleared May 01, 1998
TROVAFLOXACIN 10G, SENSI-DISC
K980683 · JTN
Becton Dickinson Microbiology Systems
Microbiology · 67d
Cleared May 01, 1998
ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER
K980815 · OCW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 59d
Cleared May 01, 1998
IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5
K980833 · JMM
Diagnostic Products Corp.
Chemistry · 58d
Cleared May 01, 1998
GII SPINAL FIXATION SYSTEM
K980852 · MNH
Karen E. Warden, M.E.B.E.
Orthopedic · 57d
Cleared May 01, 1998
SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL
K980965 · ELW
Cavex Holland BV
Dental · 46d
Cleared May 01, 1998
SCMD-1000
K980985 · HNO
Howard Instruments, Inc.
Ophthalmic · 45d
Cleared May 01, 1998
MG
K981192 · JGJ
Abbott Laboratories
Chemistry · 29d
Cleared May 01, 1998
CREATINE KINASE (CK)
K981218 · CGS
Abbott Laboratories
Chemistry · 28d
Cleared May 01, 1998
IRON
K981241 · JIY
Abbott Laboratories
Chemistry · 25d
Cleared May 01, 1998
IRMA BLOOD ANALYSIS SYSTEM
K981270 · CGZ
Diametrics Medical, Inc.
Chemistry · 24d
Cleared May 01, 1998
N-ASSAY L D-BIL
K981276 · CIG
Crestat Diagnostics, Inc.
Chemistry · 23d
Cleared May 01, 1998
ELECSYS AFP
K981282 · LOJ
Roche Diagnostics GmbH
Immunology · 23d
Cleared May 01, 1998
TBIL
K981336 · CIG
Abbott Laboratories
Chemistry · 18d
Cleared May 01, 1998
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
K981354 · LOJ
Beckman Instruments, Inc.
Immunology · 17d
Cleared May 01, 1998
PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER...
K981368 · FOZ
Catheter Innovations, Inc.
General Hospital · 16d
Cleared May 01, 1998
PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER...
K981382 · FOZ
Catheter Innovations, Inc.
General Hospital · 15d