FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

Filters: Cardiovascular ×
18,151 results
14161–14184 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 20, 1987
ENDOMYOCARDIAL BIOPSY DEVICE
K870186 · DWZ
Mansfield Scientific, Inc.
Cardiovascular · 35d
Cleared Feb 19, 1987
MTC 6210A CARDIAC OUTPUT COMPUTER
K854371 · DXG
Nihon Kohden America, Inc.
Cardiovascular · 478d
Cleared Feb 19, 1987
KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263
K862261 · DXG
Kontron Instruments, Inc.
Cardiovascular · 251d
Cleared Feb 19, 1987
BIOMA 2000
K862808 · DXG
E.B.S., Inc.
Cardiovascular · 211d
Cleared Feb 19, 1987
RMI FEMORAL VENOUS DRAINAGE CANNULA
K863740 · DWF
Research Medical, Inc.
Cardiovascular · 149d
Cleared Feb 19, 1987
MODIFIED STBP-680
K863891 · DXN
Quinton, Inc.
Cardiovascular · 136d
Cleared Feb 19, 1987
AMPLATZ MOVEABLE CORE GUIDEWIRE
K864058 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 122d
Cleared Feb 19, 1987
Q700 ELECTROCARDIOGRAPH
K864700 · DPS
Quinton, Inc.
Cardiovascular · 79d
Cleared Feb 19, 1987
MODIFIED GAS-STAT(TM) MONITORING SYSTEM
K864703 · DTY
Cardiovascular Devices, Inc.
Cardiovascular · 79d
Cleared Feb 19, 1987
SCHNEIDER-SHILEY GUIDE WIRE
K864787 · DQX
Shiley, Inc.
Cardiovascular · 73d
Cleared Feb 19, 1987
STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP
K864890 · KRI
Shiley, Inc.
Cardiovascular · 66d
Cleared Feb 19, 1987
INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER
K864895 · DTN
Johnson & Johnson Professionals, Inc.
Cardiovascular · 66d
Cleared Feb 19, 1987
NUMED BALLOON ANGIOGRAPHIC CATHETERS
K864940 · DQO
NuMED, Inc.
Cardiovascular · 64d
Cleared Feb 19, 1987
APPLISCOPE
K864978 · DPS
Grandcor Medical Systems
Cardiovascular · 59d
Cleared Feb 19, 1987
ASTRA T2, T4 AND T6
K865013 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 58d
Cleared Feb 19, 1987
ELECTROCARDIOGRAPH
K865031 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 58d
Cleared Feb 19, 1987
PREGELLED DISPOS. ELECTRODE,SILVER-SILVER CHLORIDE
K865090
Labeltape Meditect, Inc.
Cardiovascular · 51d
Cleared Feb 13, 1987
MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH
K864705 · DYB
Quinton, Inc.
Cardiovascular · 73d
Cleared Feb 12, 1987
IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM
K870039 · DSF
Par Microsystems Corp.
Cardiovascular · 38d
Cleared Feb 10, 1987
DATASCOPE BALLOON DILATATION CATHETER
K863608
Datascope Corp.
Cardiovascular · 147d
Cleared Feb 10, 1987
MULTILITH 3 MODELS 1350, 3350, 1370, 3370
K863898 · DXY
Ela Medical, Inc.
Cardiovascular · 126d
Cleared Feb 10, 1987
COLIN STBP-780 STRESS TEST BLOOD PRESSURE MONITOR
K864654 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 74d
Cleared Feb 10, 1987
MEDI-TRACE INFANT ELECTRODE
K864722 · DRX
Graphic Controls Corp.
Cardiovascular · 69d
Cleared Feb 06, 1987
FRANTZ MEDICAL ELECTRODE
K863508 · DXR
Frantz Medical Development, Ltd.
Cardiovascular · 150d