FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
9385–9408 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 28, 1999
PROWLER PLUS INFUSION CATHETER
K993266 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 28d
Cleared Oct 27, 1999
OXYCONALPHA WITH OPTION ECG
K984465 · LOS
Erich Jaeger B.V.
Cardiovascular · 315d
Cleared Oct 26, 1999
SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES
K982521 · DRX
Leonhard Lang Co.
Cardiovascular · 463d
Cleared Oct 25, 1999
INTELLISYSTEM II COLOR MONITOR
K993341 · MAV
Merit Medical Systems, Inc.
Cardiovascular · 20d
Cleared Oct 22, 1999
SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER
K990713 · DRB
Spectranetics Corp.
Cardiovascular · 232d
Cleared Oct 21, 1999
ZOLL M SERIES 12SL ANALYSIS OPTION
K991556 · MKJ
Zoll Medical Corp
Cardiovascular · 170d
Cleared Oct 21, 1999
HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A
K993171 · DSI
Hewlett-Packard Co.
Cardiovascular · 30d
Cleared Oct 21, 1999
.010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC...
K993257 · DQX
Micro Therapeutics, Inc.
Cardiovascular · 22d
Cleared Oct 20, 1999
CASE 8000 EXERCISE TESTING SYSTEM
K991014 · LOS
General Electric Medical Systems...
Cardiovascular · 208d
Cleared Oct 19, 1999
TES-20
K992425 · MWJ
Tes Electrical Electronic Corp.
Cardiovascular · 90d
Cleared Oct 15, 1999
DAIWA MODEL 180
K983616 · DXN
Daiwa Products, Inc.
Cardiovascular · 366d
Cleared Oct 15, 1999
LUMA-CATH FIXED CURVE EP CATHETERS
K991025 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 200d
Cleared Oct 15, 1999
PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
K992478 · DXN
Hewlett-Packard, Healthcare Solutions...
Cardiovascular · 81d
Cleared Oct 12, 1999
ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800
K992056 · KRH
Sulzer Carbomedics, Inc.
Cardiovascular · 116d
Cleared Oct 12, 1999
VISTA BRITE TIP CATHETERS
K992673 · DQY
Cordis Corp.
Cardiovascular · 63d
Cleared Oct 08, 1999
CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS
K992347 · DQO
Cordis Corp.
Cardiovascular · 86d
Cleared Oct 07, 1999
ANEROID SPHYGMOMANOMETER
K990638 · DXN
Genmed, Inc.
Cardiovascular · 223d
Cleared Oct 07, 1999
COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR
K991452 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 164d
Cleared Oct 07, 1999
INTRODUCER SHEATH, VESSEL DILATOR
K992309 · DYB
Boston Scientific Corp
Cardiovascular · 90d
Cleared Oct 07, 1999
ECG MINIMONITOR, MODEL CG-5000
K992696 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 56d
Cleared Oct 05, 1999
MBA
K993057 · DTL
Merit Medical Systems, Inc.
Cardiovascular · 22d
Cleared Oct 04, 1999
CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078
K991531 · DRF
Cordis Webster, Inc.
Cardiovascular · 154d
Cleared Oct 01, 1999
POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
K990276 · KRJ
Porous Media Corp.
Cardiovascular · 246d
Cleared Oct 01, 1999
T-ANASTAFLO
K990396 · DWF
Edwards Lifesciences Research Medical
Cardiovascular · 234d