FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
164905–164928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 18, 1980
INFANT VENTILATOR, (RESPIRATOR) PLAN B
K802583 · CBK
Healthdyne, Inc.
Anesthesiology · 59d
Cleared Dec 18, 1980
AMERICAN HEYER-SCHULTE LOW PROFILE VALVE
K802586 · JXG
American Heyer Schulte
Neurology · 59d
Cleared Dec 18, 1980
ENDOTRACHEAL TUBE HOLDER
K802601 · CBH
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 58d
Cleared Dec 18, 1980
RHEUMATOID FACTOR TEST SYSTEMS
K802688 · DHR
Bd Becton Dickinson Vacutainer...
Immunology · 50d
Cleared Dec 18, 1980
URINE COLLECTION BAG TYPE 2132V
K802729 · KNX
Bio D Corp.
Gastroenterology & Urology · 45d
Cleared Dec 18, 1980
URINE COLLECTION BAG TYPE AP2132V
K802732 · KNX
Bio D Corp.
Gastroenterology & Urology · 45d