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
148825–148848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 1985
AIRVIT MODEL 8500
K843594 · HQE
Lasermed Corp.
Ophthalmic · 211d
Cleared Apr 11, 1985
BRAIN FUNCTION MAPPING OPTION FOR PATHF
K843598 · GWK
Nicolet Biomedical Instruments
Neurology · 211d
Cleared Apr 11, 1985
SIEMENS SIRECUST 404N NEONATAL MONITOR
K844187 · DRT
Siemens Medical Solutions USA, Inc.
Cardiovascular · 164d
Cleared Apr 11, 1985
CARDIOSTAT 1 ECG RECORDER
K844392 · DPS
Siemens Elema AB
Cardiovascular · 149d
Cleared Apr 11, 1985
CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE
K850107 · GXZ
Nicolet Biomedical Instruments
Neurology · 91d
Cleared Apr 11, 1985
EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG
K850108 · GXY
Nicolet Biomedical Instruments
Neurology · 91d
Cleared Apr 11, 1985
ELECTROENCEPHALOGRAPH EEG
K850259 · GWQ
Nicolet Biomedical Instruments
Neurology · 79d
Cleared Apr 11, 1985
VIGGO CONNECTA 3-WAY INFUSION STOPCOCK
K850280 · FMG
Viggo Products
General Hospital · 78d
Cleared Apr 11, 1985
VIGGO SECALON T CATHETER
K850460 · FOZ
Viggo Products
General Hospital · 64d
Cleared Apr 11, 1985
IMPLANTABLE ELECTRODE LEAD 030-269 USING POLYURETH
K851296 · DTB
Telectronics, Inc.
Cardiovascular · 10d
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