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
142993–143016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 1986
INSERT EARPHONES
K862363 · GWJ
Cadwell Laboratories, Inc.
Neurology · 86d
Cleared Sep 17, 1986
RESISTANT 6 MIC PANEL
K862978 · JWY
Pasco Laboratories, Inc.
Microbiology · 41d
Cleared Sep 17, 1986
CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH)
K863116 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 34d
Cleared Sep 17, 1986
3M CORNEAL SYSTEM (CORNEAL PRESERVATION MEDIUM)
K863129 · LYX
3M Company
Ophthalmic · 33d
Cleared Sep 17, 1986
CHOLINESTERASE (BTC) REAGENT
K863203 · DIH
Sigma Diagnostics, Inc.
Chemistry · 29d
Cleared Sep 17, 1986
ALBUMIN (BCP)
K863226 · CJW
Sigma Diagnostics, Inc.
Chemistry · 27d
Cleared Sep 17, 1986
TOTAL BILIRUBIN PROCEDURE
K863262 · CIG
Data Medical Associates, Inc.
Chemistry · 23d
Cleared Sep 17, 1986
PRECIMAT (R) IGA, G, M
K863352 · CZP
Boehringer Mannheim Corp.
Immunology · 19d
Cleared Sep 17, 1986
PHADIOTOP (TM) RIA/PHADIOTOP (TM) EIA
K863355 · DHB
Pharmacia, Inc.
Immunology · 19d
Cleared Sep 17, 1986
BYRON NASAL SEPTAL BUTTON
K863398 · FZE
Byron Medical
General & Plastic Surgery · 14d
Cleared Sep 17, 1986
BYRON DORSAL COLUMELLA IMPLANT
K863399 · FZE
Byron Medical
General & Plastic Surgery · 14d
Cleared Sep 17, 1986
BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR
K863400 · LZK
Byron Medical
General & Plastic Surgery · 14d
Cleared Sep 17, 1986
MICROBIPOLATOR
K863414 · GEI
Treace Medical, Inc.
General & Plastic Surgery · 14d
Cleared Sep 17, 1986
BYRON BIVALVE NASAL SPLINTS
K863430 · FZE
Byron Medical
General & Plastic Surgery · 13d
Cleared Sep 17, 1986
MODEL 8900 ND:YAG LASER
K863433 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 13d
Cleared Sep 17, 1986
DUAL FORCEPLATE
K863443 · KHX
Neurocom International, Inc.
Physical Medicine · 12d
Cleared Sep 17, 1986
MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST
K863485 · LLH
Marion Laboratories, Inc.
Microbiology · 8d
Cleared Sep 16, 1986
RIGHT-DAY OVULATION HOME TEST
K861354 · CEP
Leeco Diagnostics, Inc.
Chemistry · 159d
Cleared Sep 16, 1986
QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL
K861420 · JJY
Quantimetrix Corp.
Chemistry · 154d
Cleared Sep 16, 1986
VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)
K861449 · GIM
Exel Intl.
Chemistry · 152d
Cleared Sep 16, 1986
ASSERACHROM D-DI KIT
K862156 · DAP
American Bioproducts Co.
Hematology · 103d
Cleared Sep 16, 1986
HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)
K862371 · LCP
Bio-Rad
Hematology · 84d
Cleared Sep 16, 1986
ABBOTT RSV EIA
K862429 · GQG
Abbott Laboratories
Microbiology · 82d
Cleared Sep 16, 1986
RESPIRASTICK ENZYME IMMUNOASSAY TEST
K862475 · GTY
Orion Diagnostica, Inc.
Microbiology · 78d