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
164137–164160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1981
HEART SENTINEL
K802900 · DSI
Totemite Medical Electronics
Cardiovascular · 114d
Cleared Mar 11, 1981
KONTRON PERCUTAEOUS DOUBLE-LUMEN
K802924 · DSP
Avco Medical Products
Cardiovascular · 113d
Cleared Mar 11, 1981
DISPOSABLE ELECTRODE FOR EKG
K803179 · DRX
Midwest Monitoring
Cardiovascular · 85d
Cleared Mar 11, 1981
140 NEOCARE AIR CONTROLLED INCUBATOR
K810067 · FMZ
Vickers America Medical Corp.
General Hospital · 57d
Cleared Mar 11, 1981
SYRINGE, ENT
K810251 · KYZ
Megaplast, Inc.
General Hospital · 41d
Cleared Mar 11, 1981
AUTOMATIC ELECTRODE PLACEMENT BELT
K810262 · GXY
Wallant Intl. Trade, Inc.
Neurology · 40d
Cleared Mar 11, 1981
CLINIX-R TOMOGRAPHIC DEVICE
K810274 · IZF
Philips Medical Systems (Cleveland),...
Radiology · 37d
Cleared Mar 11, 1981
ALPHA I AND ALPHA II
K810276 · IZL
Porta Ray, Inc.
Radiology · 37d
Cleared Mar 11, 1981
PREGELLED DISPOS. ELECTROSURG. GROUND EL
K810277 · GEI
Conmedcorp
General & Plastic Surgery · 37d
Cleared Mar 11, 1981
AUTOMATIC TEFLON INJECTION SYRINGE
K810284 · KCP
R. Wolf Medical Instruments Corp.
Ear, Nose, Throat · 37d
Cleared Mar 11, 1981
RHEUMATOID FACTOR REAGENT TEST KIT
K810306 · DHR
Beckman Instruments, Inc.
Immunology · 34d
Cleared Mar 11, 1981
ZONOGRAPH 6
K810307 · IZF
Siemens Corp.
Radiology · 34d
Cleared Mar 11, 1981
RUBELLA ANTIBODIES TEST REAGENTS
K810309 · GOL
Calbiochem-Behring Corp.
Immunology · 34d
Cleared Mar 11, 1981
POROCOAT TM TOWNLEY ANATOMIC KNEE
K810326 · JWH
Depuy, Inc.
Orthopedic · 30d
Cleared Mar 11, 1981
STRESS TEST SYSTEM
K810357 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 29d
Cleared Mar 11, 1981
BAIM TM CORONARY SINUS FLOW THERMAL
K810360 · DQO
Electro-Catheter Corp.
Cardiovascular · 29d
Cleared Mar 11, 1981
DIGITAL RADIOGRAPHY SYSTEM
K810364 · JAA
Adac Laboratories
Radiology · 27d
Cleared Mar 11, 1981
RHEUMATOID FACTORS REFERENCE SERUM
K810404 · DHR
Calbiochem-Behring Corp.
Microbiology · 21d
Cleared Mar 11, 1981
STERILE WET DRESSING PACK
K810406
W.G. Whitney Corp.
General & Plastic Surgery · 21d
Cleared Mar 11, 1981
NARCO TLECARE MINIATURE PRESSURE DOME
K810431 · DRS
Narco Bio-Systems
Cardiovascular · 20d
Cleared Mar 11, 1981
BURRON PERCUTANEOUS INDUCER SET
K810460 · DQY
Burron Medical Products, Inc.
Cardiovascular · 19d
Cleared Mar 11, 1981
BURRON CENTRAL VEIN CATHERIZATION KIT
K810461 · DQY
Burron Medical Products, Inc.
Cardiovascular · 19d
Cleared Mar 11, 1981
PHADEZYM RAST TEST
K810462 · DHB
Pharmacia, Inc.
Immunology · 19d
Cleared Mar 11, 1981
DCA DIGOX-SYN RIA TEST
K810477 · DOG
Diagnostic Corp. of America
Toxicology · 16d