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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
144841–144864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1986
KODAK T-MAT M FILM SO-245
K860754 · IXA
Eastman Kodak Company
Radiology · 6d
Cleared Mar 06, 1986
KODAK MIN-R FAST SCREEN SO-459
K860755 · EAM
Eastman Kodak Company
Radiology · 6d
Cleared Mar 05, 1986
MONOFIXATEUR
K854336 · HWC
Ortopedia GmbH
Orthopedic · 128d
Cleared Mar 05, 1986
SKD ELECTROCHEMICAL SYSTEM (ECS)
K854723 · CEM
Smithkline Diagnostics, Inc.
Chemistry · 103d
Cleared Mar 05, 1986
INTRAOCULAR FORCEPS & SCISSORS
K854869 · HNR
Mira, Inc.
Ophthalmic · 91d
Cleared Mar 05, 1986
LINK METAL-BACKED ACETABULAR CUPS
K854935 · JDL
Link America, Inc.
Orthopedic · 85d
Cleared Mar 05, 1986
STORZ E9040 & E9046 DIAMOND KNIVES
K855050 · HNN
Storz Instrument Co.
Ophthalmic · 78d
Cleared Mar 05, 1986
NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95
K855079 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 76d
Cleared Mar 05, 1986
CPK (UV) REAGENT KIT
K855188 · JHS
Technostics Intl.
Chemistry · 69d
Cleared Mar 05, 1986
SYSTEMS PLUS
K860014 · HQE
United Surgical Corp.
Ophthalmic · 61d
Cleared Mar 05, 1986
ABL330 ACID BASE LABORATORY
K860057 · CHL
Radiometer America, Inc.
Chemistry · 58d
Cleared Mar 05, 1986
ENCORE PROLACTIN REAGENT
K860221 · CFT
Hybritech, Inc.
Chemistry · 42d
Cleared Mar 05, 1986
CASTLE 7538 FLOOR LOADING WASHER
K860263 · LDS
Castle Co.
General Hospital · 37d
Cleared Mar 05, 1986
ELLIK EVACUATOR
K860266 · KQT
R. J. Ltd., Ind.
Gastroenterology & Urology · 37d
Cleared Mar 05, 1986
IL TEST PHENYTOIN
K860286 · DIP
Allied Instrumentation Laboratory
Toxicology · 36d
Cleared Mar 05, 1986
ACID PHOSPHATASE REAGENT SET
K860476 · CKE
Sterling Diagnostics, Inc.
Chemistry · 26d
Cleared Mar 05, 1986
MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY
K860490 · JHI
Medix Biotech, Inc.
Chemistry · 23d
Cleared Mar 05, 1986
SUNBED/CANOPY, MODELS GTI 24N,30R,30RE & 37RE
K860509 · FTC
Ecomatic GmbH, Frankfurt, F.R.G.
General & Plastic Surgery · 22d
Cleared Mar 05, 1986
TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT
K860542 · JHI
Hybritech, Inc.
Chemistry · 21d
Cleared Mar 05, 1986
NORDIC SUN 24 LAMP TANNING BED
K860566 · FTC
Nordic Sun Corporation of America
General & Plastic Surgery · 19d
Cleared Mar 05, 1986
NORDIC SUN HOME TANNING UNIT
K860567 · FTC
Nordic Sun Corporation of America
General & Plastic Surgery · 19d
Cleared Mar 05, 1986
MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS
K860598 · EYQ
Procter & Gamble Mfg. Co.
Gastroenterology & Urology · 14d
Cleared Mar 05, 1986
MARKOPTIC IMPROVED ARTHROSCOPE
K860607 · HRX
Markoptic
Orthopedic · 14d
Cleared Mar 04, 1986
COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT
K853009 · JSS
Roche Diagnostic Systems, Inc.
Microbiology · 231d