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
122473–122496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1991
HALL TRANSCEERVICAL SAFE ACCESS CANNULA(TM)
K904645 · HET
Hall Medical Laboratories
Obstetrics & Gynecology · 138d
Cleared Feb 26, 1991
COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE
K904812 · EBF
Alpha-Dent
Dental · 124d
Cleared Feb 26, 1991
ECLIPSE ICA CHOLESTEROL
K905145 · CHH
Biotope, Inc.
Chemistry · 103d
Cleared Feb 26, 1991
THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH
K905254 · LWJ
Depuy, Inc.
Orthopedic · 95d
Cleared Feb 26, 1991
DENTHESIVE
K905302 · KLE
Kulzer, Inc.
Dental · 90d
Cleared Feb 26, 1991
WLW
K905320 · EJT
Ivoclar North America, Inc.
Dental · 90d
Cleared Feb 26, 1991
PLATINUM FOIL, VARIOUS SIZES
K905321 · EIH
Ivoclar North America, Inc.
Dental · 90d
Cleared Feb 26, 1991
MAXIGOLD
K905327 · EJT
Ivoclar North America, Inc.
Dental · 90d
Cleared Feb 26, 1991
WILL-CERAM W
K905329 · EJT
Ivoclar North America, Inc.
Dental · 90d
Cleared Feb 26, 1991
GGT REAGENT
K905618 · JPZ
Amresco, Inc.
Chemistry · 74d
Cleared Feb 26, 1991
M. CAT. BUTYRATE DISC
K905666 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 70d
Cleared Feb 26, 1991
COULTER DART AST (GOT) REAGENT
K905771 · CIT
Coulter Electronics, Inc.
Chemistry · 61d
Cleared Feb 26, 1991
ALBUMIN REAGENT SET
K905776 · CJW
Biochemical Trade, Inc.
Toxicology · 61d
Cleared Feb 26, 1991
HFQ SERIES CONTROLS AND GENERATORS
K905799 · IZO
Bennett X-Ray Corp.
Radiology · 88d
Cleared Feb 26, 1991
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI
K905820 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 57d
Cleared Feb 26, 1991
PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200
K910105 · GFT
International Technidyne Corp.
Hematology · 54d
Cleared Feb 26, 1991
CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST
K910240 · CHH
Crystal Diagnostics, Inc.
Chemistry · 35d
Cleared Feb 26, 1991
LAPAROSCOPIC ASPIRATION PROBE
K910340 · HET
Davol, Inc.
Obstetrics & Gynecology · 29d
Cleared Feb 26, 1991
ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL
K910416 · LGD
Abbott Laboratories
Microbiology · 27d
Cleared Feb 26, 1991
BIOCLONE'S ELEGANCE HCG ELISA KIT
K910420 · JHI
Bioclone Australia Pty , Ltd.
Chemistry · 27d
Cleared Feb 26, 1991
J&B OPTICAL FRAMES
K910626 · HQZ
J & B Optical, Inc.
Ophthalmic · 14d
Cleared Feb 25, 1991
MODIFIED LIFEPAK 9 MONITOR/DEFIBRILLATOR
K902288 · LDD
Physio-Control Corp.
Cardiovascular · 279d
Cleared Feb 25, 1991
EMBOLECTOMY CATHETER
K902327 · DXE
Clincal Instruments Corp.
Cardiovascular · 277d
Cleared Feb 25, 1991
INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH.
K902627 · KRB
Biometric Research Institute, Inc.
Cardiovascular · 257d