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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
143953–143976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1986
ENZYMUN TEST TBG
K862109 · CEE
Boehringer Mannheim Corp.
Chemistry · 27d
Cleared Jun 30, 1986
RAPID BACTERIURIA SCREEN (RBS)
K862195 · JXA
New Horizons Diagnostics Co.
Microbiology · 21d
Cleared Jun 30, 1986
TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)
K862216 · LGD
Labsystems, Inc.
Microbiology · 20d
Cleared Jun 27, 1986
LYOFOAM WOUND DRESSINGS
K860085 · NAD
Acme United Corp.
General & Plastic Surgery · 169d
Cleared Jun 27, 1986
CRESOLPHTHALEIN COMPLEXONE, CALCIUM
K860664 · CIC
Amresco, Inc.
Chemistry · 123d
Cleared Jun 27, 1986
SUCROSEP HUMAN PROLACTIN (HPR) IRMA
K861271 · CFT
Boots-Celltech Diagnostics, Inc.
Chemistry · 84d
Cleared Jun 27, 1986
ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE
K861361 · CHP
Serono Diagnostics, Inc.
Chemistry · 78d
Cleared Jun 27, 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)
K861387 · JHS
Eastman Kodak Company
Chemistry · 74d
Cleared Jun 27, 1986
TB SERIES BIPOLAR PACING LEADS
K861403 · LDF
Oscor Medical Corp.
Cardiovascular · 73d
Cleared Jun 27, 1986
PROGROUP (TM) AUTOMATED LIQUID HANDLING SYSTEM
K861580 · JQW
Cetus Corp.
Chemistry · 60d
Cleared Jun 27, 1986
TRIGLYCERIDES GPO-TRINDER
K861635 · CDT
Catachem, Inc.
Chemistry · 59d
Cleared Jun 27, 1986
OSTEONICS ELBOW PROSTHESIS
K861680 · JDC
Osteonics Corp.
Orthopedic · 57d
Cleared Jun 27, 1986
TWIN BUN/GLUCOSE
K861775 · CDW
Boehringer Mannheim Corp.
Chemistry · 50d
Cleared Jun 27, 1986
TWIN TRIGLYCERIDES GPO/CHOLESTEROL
K861793 · CDT
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Jun 27, 1986
RICH-MAR SPINA-MOBILIZOR
K861832 · ITH
Rich-Mar Corp.
Physical Medicine · 45d
Cleared Jun 27, 1986
WORTHINGTON HDL PRECIPITATING REAGENT SET
K861926 · LBR
Cooper Biomedical, Inc.
Chemistry · 39d
Cleared Jun 27, 1986
DERMISTRIP
K861972 · NAD
Kells Medical, Inc.
General & Plastic Surgery · 37d
Cleared Jun 27, 1986
TOTAL BILIRUBIN TEST KIT
K861998 · CIG
Ciba Corning Diagnostics Corp.
Chemistry · 35d
Cleared Jun 27, 1986
MEDISYSTEMS PHERESIS NEEDLE
K862002 · FIE
Medisystems Corp.
Gastroenterology & Urology · 35d
Cleared Jun 27, 1986
STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH
K862006 · DQO
Cordis Corp.
Cardiovascular · 31d
Cleared Jun 27, 1986
POLYPECTOMY SNARE
K862060 · KNS
Endovations
Gastroenterology & Urology · 28d
Cleared Jun 27, 1986
ARIZONA CONDYLAR TIBIAL PLATEAU
K862125 · HRY
Depuy, Inc.
Orthopedic · 24d
Cleared Jun 27, 1986
RAICHEM CHOLINESTERASE REAGENT
K862168 · DIH
Reagents Applications, Inc.
Toxicology · 18d
Cleared Jun 27, 1986
EMIT QUINIDINE ASSAY
K862214 · LBZ
Syva Co.
Toxicology · 17d