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
164977–165000 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1981
BECKMAN THEOPHYLLINE REAGENT TEST KIT
K810578 · KLS
Beckman Instruments, Inc.
Toxicology · 10d
Cleared Mar 13, 1981
ELECTRODE, PACEMAKER PERMANENT
K810582 · DTB
Pacesetter Systems
Cardiovascular · 10d
Cleared Mar 13, 1981
NEUROPAC ULTRA I
K810593 · GZJ
Medical Devices, Inc.
Neurology · 8d
Cleared Mar 13, 1981
CURITY 100% SILICONE IRRIGATION FOLEY
K810691 · EZL
The Kendal Co.
Gastroenterology & Urology
Cleared Mar 12, 1981
SILICONE ELBOW, BED AND CHAIR PADS
K810440 · KIC
Fred Sammons, Inc.
Physical Medicine · 21d
Cleared Mar 11, 1981
SERIES 4000 STRESS & EXERCISE SYSTEM
K801903 · DSI
Instruments For Cardiac Research
Cardiovascular · 212d
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