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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
149425–149448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1985
DIAGNOSTIC ULTRASOUND 105 & 110
K842539 · JOP
Diagnostic Ultrasound Corp.
Cardiovascular · 286d
Cleared Apr 10, 1985
Q-DOP
K843058 · JOP
Quinton, Inc.
Cardiovascular · 250d
Cleared Apr 10, 1985
IR-192 IMPLANT
K844248 · IWA
Rads S.L., Inc.
Radiology · 159d
Cleared Apr 10, 1985
GL ULTRASOUND SECTOR 170
K844393 · IYO
Gl Ultrasound , Ltd.
Radiology · 148d
Cleared Apr 10, 1985
SYSTEM SIRECUST 400 SIEMENS SIRECUST 456-1A
K844791 · DSI
Analogic Corp.
Cardiovascular · 121d
Cleared Apr 10, 1985
RABBIT-PERSONAL COMPUTER FOR WOMEN
K845009 · LHD
Sanimor, Inc.
Obstetrics & Gynecology · 105d
Cleared Apr 10, 1985
ELECATH TORKFLOAT PACING PROBE
K850065 · DTB
Electro-Catheter Corp.
Cardiovascular · 92d
Cleared Apr 10, 1985
SCIMED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILAT
K850075 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 91d
Cleared Apr 10, 1985
COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER
K850139 · KRJ
Rapid Diagnostic Laboratories, Inc.
Cardiovascular · 86d
Cleared Apr 10, 1985
CARDIAC SECTOR PROBE 3.5. MHZ
K850145 · JOP
Siemens Medical Solutions USA, Inc.
Cardiovascular · 86d
Cleared Apr 10, 1985
CARDIAC SECTOR PROBE 5.0 MHZ
K850216 · JOP
Siemens Medical Solutions USA, Inc.
Cardiovascular · 78d
Cleared Apr 10, 1985
CORONARY INFUSION CATHETER W/SIDEHOLES
K850353 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 71d
Cleared Apr 10, 1985
BASICAM COUNTER BALANCE CAMERA
K850463 · IYX
Siemens Gammasonics, Inc.
Radiology · 63d
Cleared Apr 10, 1985
DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H
K850575 · JJY
American Dade
Chemistry · 56d
Cleared Apr 10, 1985
OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR
K850622 · LDF
Oscor Medical Corp.
Cardiovascular · 50d
Cleared Apr 10, 1985
PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD
K850652 · DTD
Pacesetter Systems
Cardiovascular · 50d
Cleared Apr 10, 1985
F-SERIES IMPLANT
K850706 · DZE
Omni Intl., Inc.
Dental · 47d
Cleared Apr 10, 1985
MILLS OPERATIVE PERIPHERAL ANGIOPLASTY CATHETER
K850760 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 44d
Cleared Apr 10, 1985
DENTAL MASSAGING PICKS
K850775 · JET
L.A.K. Ent., Inc.
Dental · 43d
Cleared Apr 10, 1985
MOBILE LEAD PLASTIC X-RAY BARRIERS
K850813 · IWX
Victoreen, Inc.
Radiology · 41d
Cleared Apr 10, 1985
MODULAR X-RAY BARRIERS
K850814 · EAK
Victoreen, Inc.
Radiology · 41d
Cleared Apr 10, 1985
LEAD PLASTIC VIEWING PANELS
K850816 · EAK
Victoreen, Inc.
Radiology · 41d
Cleared Apr 10, 1985
PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID
K850820 · DYB
Universal Medical Instrument Corp.
Cardiovascular · 41d
Cleared Apr 10, 1985
SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR
K850823 · IZO
Philips Medical Systems (Cleveland),...
Radiology · 41d