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
9697–9720 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 25, 1998
MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE
K974220 · DPS
Micromedical, Inc.
Cardiovascular · 286d
Cleared Aug 24, 1998
COBE CLOSED VENOUS RESERVOIR BAGS WITH SMARX T, MODELS VRB 1200 AND VRB 1800
K980786 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 175d
Cleared Aug 24, 1998
SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR
K982730 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 39d
Cleared Aug 21, 1998
ELECTROCARDIOGRAPHS
K972587 · LOS
Dr. Lee Co., Ltd.
Cardiovascular · 406d
Cleared Aug 20, 1998
PTA BALLOON CATHETER
K980390 · LIT
Cook, Inc.
Cardiovascular · 199d
Cleared Aug 20, 1998
NPB3900 SERIES PATIENT MONITORS
K980411 · MHX
Analogic Corp.
Cardiovascular · 198d
Cleared Aug 20, 1998
SABRATEK PATIENT HOME MANAGEMENT SYSTEM
K980619 · MHX
Sabratek Corp.
Cardiovascular · 183d
Cleared Aug 20, 1998
BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX
K981747 · DRS
Sunscope Intl., Inc.
Cardiovascular · 94d
Cleared Aug 19, 1998
CARDIOVISION SOFTWARE, MODEL S-CV5-96
K981807 · DPS
Shl Telemedicine International , Ltd.
Cardiovascular · 90d
Cleared Aug 18, 1998
SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER
K981788 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 90d
Cleared Aug 18, 1998
ENVOY AND VISTA BRITE TIP
K982632 · DQY
Cordis Corp.
Cardiovascular · 26d
Cleared Aug 18, 1998
6F ENVOY GUIDING CATHETER
K982770 · DQY
Cordis Corp.
Cardiovascular · 26d
Cleared Aug 14, 1998
DINAMAP MPS SELECT PORTABLE MONITOR
K982342 · MSX
Critikon Company, LLC
Cardiovascular · 39d
Cleared Aug 12, 1998
ANS 2000 ECG MONITOR AND RESPIRATION PACER
K973426 · DPS
D. E. Hokanson, Inc.
Cardiovascular · 336d
Cleared Aug 12, 1998
D903 AVANT ADULT HOLLOW FIBER OXYGENATOR
K980600 · JOW
Dideco S.P.A.
Cardiovascular · 176d
Cleared Aug 12, 1998
BETTER-BLADDER (BB)
K981284 · DTN
Circulatory Technology, Inc.
Cardiovascular · 126d
Cleared Aug 12, 1998
LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT...
K981782 · DYB
Arrow Intl., Inc.
Cardiovascular · 84d
Cleared Aug 12, 1998
MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR
K982697 · DSI
Mennen Medical, Inc.
Cardiovascular · 9d
Cleared Aug 11, 1998
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
K980453 · DQY
Boston Scientific Scimed, Inc.
Cardiovascular · 187d
Cleared Aug 11, 1998
SELECTOR DIAGNOSTIC CATHETER
K982077 · DQO
Boston Scientific Scimed, Inc.
Cardiovascular · 60d
Cleared Aug 10, 1998
CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210
K982415 · DRF
Cordis Webster, Inc.
Cardiovascular · 28d
Cleared Aug 10, 1998
AECD ARRHYTHMIA DETECTION SOFTWARE
K982710 · MKJ
Cardiac Science, Inc.
Cardiovascular · 6d
Cleared Aug 07, 1998
CONTOR TABLE SURFACE
K973705 · DWJ
Hill-Rom, Inc.
Cardiovascular · 312d
Cleared Aug 07, 1998
MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE
K980016 · MOP
Genzyme Surgical Product (Genzyme...
Cardiovascular · 217d