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

Filters: Cleared only ×
176,076 results
165745–165768 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 1980
CARBONACRYL
K802976
Ipos Luneburg
Physical Medicine · 28d
Cleared Dec 19, 1980
IPOCARBON STRETCH STOCKINETTE
K802977
Ipos Luneburg
Physical Medicine · 28d
Cleared Dec 19, 1980
DISPOSABLE STERILE LAP SPONGE
K802980 · KKX
Anago, Inc.
General Hospital · 25d
Cleared Dec 19, 1980
GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG.
K802982 · GDY
Stanford Laboratories
General & Plastic Surgery · 25d
Cleared Dec 18, 1980
SILASTIC II MAMMARY IMPLANT
K801175
Dow Corning Corp. Healthcare...
General & Plastic Surgery · 216d
Cleared Dec 18, 1980
THE BRAVO NEW PARALLEL FLOW DIALYZER
K801633 · FJG
Bellco Artifidial Organ Spec., Inc.
Gastroenterology & Urology · 156d
Cleared Dec 18, 1980
MEDCOMP SUBCLAVIAN CATHETER
K801672 · LFJ
Medical Components, Inc.
Gastroenterology & Urology · 149d
Cleared Dec 18, 1980
3M I-125 SEEDS IN ABSORBABLE CARRIER
K801748 · KXK
3M Company
Radiology · 143d
Cleared Dec 18, 1980
HF-100 DIALYZER
K802092 · FJI
Bio-Med Corp.
Gastroenterology & Urology · 107d
Cleared Dec 18, 1980
RUBELLA ELISA REAGENTS RUBELLA IGG ANTI
K802102 · GOL
Calbiochem-Behring Corp.
Immunology · 106d
Cleared Dec 18, 1980
NEPHROSS DIALYZER
K802114 · FJI
Organon Teknika Corp.
Gastroenterology & Urology · 106d
Cleared Dec 18, 1980
CLIRANS TH13 HOLLOW FIBER DIALYZER
K802122 · FJI
Terumo America, Inc.
Gastroenterology & Urology · 105d
Cleared Dec 18, 1980
EIA RUBELLA-G
K802339 · GOL
Beckman Instruments, Inc.
Microbiology · 83d
Cleared Dec 18, 1980
CLIRANS TH10 HOLLOW FIBER DIALYZER
K802441 · FJI
Terumo America, Inc.
Gastroenterology & Urology · 72d
Cleared Dec 18, 1980
TOXOTEST-MT EIKEN KIT
K802452 · GMM
Syn-Kit, Inc.
Microbiology · 71d
Cleared Dec 18, 1980
CLOSTRIDIUM DIFFICILE AGAR BASE
K802495 · JSJ
Oxoid U.S.A., Inc.
Microbiology · 69d
Cleared Dec 18, 1980
RUBELISA IGM TEST KIT
K802508 · GOL
M.A. Bioproducts
Microbiology · 64d
Cleared Dec 18, 1980
PFIZONIC 150 ULTRASOUND SCANNER
K802528 · IYO
Pfizer Medical Systems, Inc.
Radiology · 63d
Cleared Dec 18, 1980
PFIZONIC 100 ULTRASOUND SCANNER
K802529 · DXK
Pfizer Medical Systems, Inc.
Radiology · 63d
Cleared Dec 18, 1980
PFIZONIC 250 ULTRASOUND SCANNER
K802530 · IYO
Pfizer Medical Systems, Inc.
Radiology · 63d
Cleared Dec 18, 1980
PFIZONIC 200 ULTRASOUND SCANNER
K802531 · IYO
Pfizer Medical Systems, Inc.
Radiology · 63d
Cleared Dec 18, 1980
PFIZONIC 300 ULTRASOUND SCANNER
K802532 · IYO
Pfizer Medical Systems, Inc.
Radiology · 63d
Cleared Dec 18, 1980
HYDROXYLATE DENTAL COMPOSITE RESTROATIVE
K802535 · EBF
Wallace A. Erickson & Co.
Dental · 64d
Cleared Dec 18, 1980
PACE-4-AUTOMATIC RIA GAMMA-COUTER
K802578 · JJJ
Philips Medical Systems (Cleveland),...
Radiology · 59d