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
173449–173472 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 1977
AKRO-SIL FOLEY KIT 30CC
K771650 · FCM
Latex Ind., Inc.
Gastroenterology & Urology · 22d
Cleared Sep 20, 1977
AKRO-SIL FOLEY KIT 5CC
K771651 · FCM
Latex Ind., Inc.
Gastroenterology & Urology · 22d
Cleared Sep 20, 1977
CATH-CARE TRAY
K771652 · FCM
Latex Ind., Inc.
Gastroenterology & Urology · 22d
Cleared Sep 20, 1977
PROBE & CATHETER
K771663 · KRB
Edwards Laboratories
Cardiovascular · 21d
Cleared Sep 20, 1977
FOOT DROP BOOT
K771676 · IQI
Medical Restraints, Inc.
Physical Medicine · 18d
Cleared Sep 20, 1977
MIN-R CASSETTE
K771682 · IXA
Eastman Kodak Company
Radiology · 14d
Cleared Sep 20, 1977
AMPLIFIER MODEL N3B-EEG
K771683 · GWL
Honeywell, Inc.
Neurology · 14d
Cleared Sep 20, 1977
CLIRANS BLOOD LINES SET
K771693 · FJK
Terumo America, Inc.
Hematology · 14d
Cleared Sep 20, 1977
CARDIO-EXERCISE TREADMILL 550
K771697 · IOL
Quinton, Inc.
Physical Medicine · 14d
Cleared Sep 20, 1977
SAIF-BOW
K771706 · DZB
Northwest Orthodontics, Inc.
Dental · 11d
Cleared Sep 20, 1977
CYMET-PLUS
K771716 · GKK
J.T. Baker Chemical Co.
Hematology · 8d
Cleared Sep 20, 1977
KARAYA ELECTRODES
K771719 · GXY
Lectec Corp.
Neurology · 8d
Cleared Sep 15, 1977
CURITY IRRIGATION TRAY
K771079 · GBX
Kendall Research Center
General & Plastic Surgery · 92d
Cleared Sep 15, 1977
CATHETER, PO2, INTRAVASUCLAR, CITADEL
K771116 · CCE
Sherwood Medical Industries
Anesthesiology · 91d
Cleared Sep 15, 1977
AVL BLOOD GAS INSTRUMENT MODEL 939
K771147 · CHL
Jones Medical Instrument Co.
Chemistry · 80d
Cleared Sep 15, 1977
SPIR-E-VAC
K771241 · CAN
Breathing Services, Inc.
Anesthesiology · 66d
Cleared Sep 15, 1977
PARALLEL PLATE DIALYZERS
K771354 · FJG
Hospal Medical Corp.
Gastroenterology & Urology · 55d
Cleared Sep 15, 1977
PRESSURE MODULE 5M1247
K771375 · FKQ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 52d
Cleared Sep 15, 1977
TOXHA TEST
K771560 · GMM
Burroughs Wellcome Co.
Toxicology · 31d
Cleared Sep 15, 1977
DUO-CATH FEMORAL
K771573 · FOZ
Medical Device Laboratories
General Hospital · 31d
Cleared Sep 15, 1977
CHOLOPAP-HDL
K771586 · CHH
Advanced Biomedical Methods, Inc.
Chemistry · 28d
Cleared Sep 15, 1977
THYROID STIMULATING HORMONE
K771590 · JLW
New England Nuclear
Chemistry · 27d
Cleared Sep 15, 1977
IMMOCHEMISTRY SYSTEM
K771603 · CZP
Beckman Instruments, Inc.
Immunology · 24d
Cleared Sep 15, 1977
CREATINE KINASE ISOENZYME SUBSTRATE SET
K771605 · JHX
Pfizer Pharmaceuticals
Chemistry · 24d