Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
153889–153912 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 19, 1984
TRISACRYL GF 05 & TRISACRYL GF 2000
K840985 · DJY
Lkb Instruments, Inc.
Chemistry · 43d
Cleared Apr 19, 1984
MATCHED COMPONENT SET RADIOIMMUNOASSAY
K841042 · CDZ
Cambridge Medical Technology
Chemistry · 38d
Cleared Apr 19, 1984
PARAMAX CHLORIDE REAGENT
K841047 · CHJ
American Dade
Toxicology · 38d
Cleared Apr 19, 1984
ACA DIGOXIN ANALYTICAL TEST PACK
K841107 · KXT
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 36d
Cleared Apr 19, 1984
ACA DIGOXIN CALLIBRATOR
K841108 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 36d
Cleared Apr 19, 1984
P-S MEDICAL CSF-FLOW CONTROL VALVE-
K841442 · JXG
P-S Medical
Neurology · 13d
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