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
153049–153072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 1984
ARGON LASER SURGICAL SYSTEM 770
K833387
Cooper Medical Corp.
General & Plastic Surgery · 202d
Cleared Apr 18, 1984
PHADEBAS RAST PHADEZYM MIX ALLERG
K840670 · DHB
Pharmacia, Inc.
Microbiology · 57d
Cleared Apr 18, 1984
CLINICAL CARE STIMULATOR
K840725
Biostim, Inc.
Neurology · 57d
Cleared Apr 18, 1984
IMMPULSE T4 ASSAY REAGENTS
K840852 · CDX
Paragon Diagnostics, Inc.
Chemistry · 54d
Cleared Apr 18, 1984
RAICHEM CREATININE REAGENT
K840872 · CGX
Reagents Applications, Inc.
Chemistry · 51d
Cleared Apr 18, 1984
EKTACHEM CLINICAL CHEM. SLIDES
K840880 · CIG
Eastman Kodak Company
Chemistry · 51d
Cleared Apr 18, 1984
HYDROXYPROGESTERONE BY RIA 17A
K840886 · JLS
Radioassay Systems Laboratories, Inc.
Chemistry · 51d
Cleared Apr 18, 1984
AMRESCO E2A REAGENT SET 0562 & 0626
K840887 · CEM
American Research Products Co.
Chemistry · 51d
Cleared Apr 18, 1984
ENDAB ESTRIOL UNCONJUGATED
K840902 · CGI
Immunotech Corp.
Chemistry · 50d
Cleared Apr 18, 1984
FREE T3 SOLID PHASE RADIOIMMUNOASSAY
K840959 · CDP
Bd Becton Dickinson Vacutainer...
Chemistry · 43d
Cleared Apr 18, 1984
BUSH NECK W/PLUG
K841409 · BYZ
Warne Surgical Products, Ltd.
General Hospital · 13d
Cleared Apr 18, 1984
BUSH NECK W/TAP
K841410 · DRM
Warne Surgical Products, Ltd.
Cardiovascular · 13d
Cleared Apr 18, 1984
ROLLED NECK W/PLUG
K841411 · BTC
Warne Surgical Products, Ltd.
Anesthesiology · 13d
Cleared Apr 18, 1984
ROLLED NECK W/TAP
K841412 · BTC
Warne Surgical Products, Ltd.
Anesthesiology · 13d
Cleared Apr 18, 1984
HYDRA-GYM ATHLETICS INC.
K841413 · BXB
Hydra Fitness Industries
Physical Medicine · 13d
Cleared Apr 17, 1984
RADIATION STERILIZATION OF SURG. GLOVES
K823234
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 533d
Cleared Apr 17, 1984
DIGITAL SPHYGMOMANOMETER UA-251
K832722 · DXN
Copal, Inc.
Cardiovascular · 249d
Cleared Apr 17, 1984
DIGITAL SPHGMOMANOMETER UA-271
K832723 · DXN
Copal, Inc.
Cardiovascular · 249d
Cleared Apr 17, 1984
RESPIRATION/8100-HEART RATE RECORDER
K833348 · DSH
Aequitron Medical, Inc.
Cardiovascular · 203d
Cleared Apr 17, 1984
EVENT TAPE RECORDER 8293
K833349 · DSH
Aequitron Medical, Inc.
Cardiovascular · 203d
Cleared Apr 17, 1984
COOPER MEDICAL MODEL 770
K833497 · LLF
Cooper Medical Corp.
Neurology · 189d
Cleared Apr 17, 1984
CONTRAST MEDIA INJECT. SET CMS
K833645 · DXT
Gish Biomedical, Inc.
Cardiovascular · 183d
Cleared Apr 17, 1984
ISOTEC DISPOS. PRESSURE TRANSDUCER
K833884
Delta Medical Industries
Cardiovascular · 160d
Cleared Apr 17, 1984
CO-SET
K833997
American Edwards Laboratories
General & Plastic Surgery · 148d