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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,151 results
10753–10776 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 24, 1995
HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER
K950004 · DPS
Aerotel, Ltd.
Cardiovascular · 294d
Cleared Oct 24, 1995
DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883
K951977 · DXN
Integrated Display Technology, Ltd.
Cardiovascular · 180d
Cleared Oct 23, 1995
5F ENVOY GUIDING CATHETER (MODIFICATION)
K954251 · DQY
Cordis Neurovascular, Inc.
Cardiovascular · 60d
Cleared Oct 20, 1995
NELLCOR SYMPHONY N-3100 BLOOD PRESSURE MONITOR
K953472 · DXN
Nellcor, Inc.
Cardiovascular · 88d
Cleared Oct 19, 1995
EAGLE 3000 PATIENT MONITOR
K952474 · DRT
Marquette Electronics, Inc.
Cardiovascular · 142d
Cleared Oct 19, 1995
6200 VITAL SIGNS MONITOR
K953415 · DPS
Bci Intl., Inc.
Cardiovascular · 91d
Cleared Oct 18, 1995
RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
K953533 · DQX
Terumo Medical Corp.
Cardiovascular · 83d
Cleared Oct 18, 1995
SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER
K953602 · LIT
Boston Scientific Corp
Cardiovascular · 77d
Cleared Oct 16, 1995
ECOTABS
K950587 · DRX
Msb , Ltd.
Cardiovascular · 249d
Cleared Oct 12, 1995
VITALOGRAPH 2110 SOFTWARE INTERFACE
K950854 · DSH
Vitalograph , Ltd.
Cardiovascular · 227d
Cleared Oct 12, 1995
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS
K951858 · DTB
Medtronic Vascular
Cardiovascular · 174d
Cleared Oct 06, 1995
ZYMED TELEMETRY SYSTEM
K951370 · DSI
Zymed Medical Instrumentation
Cardiovascular · 193d
Cleared Oct 06, 1995
AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM)
K951684 · JOW
Digital Air Corp.
Cardiovascular · 178d
Cleared Oct 06, 1995
AFFINITY ARTERIAL BLOOD FILTER
K952532 · DTM
Avecor Cardiovascular, Inc.
Cardiovascular · 127d
Cleared Oct 06, 1995
DIASTAT VASCULAR ACCESS GRAFT
K953287 · DYF
W.L. Gore & Associates, Inc.
Cardiovascular · 85d
Cleared Oct 06, 1995
DIASTAT VASCULAR ACCESS GRAFT
K953288 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 84d
Cleared Oct 05, 1995
CATHETER, BALLOON TYPE
K950398 · DQO
Interventional Therapeutics Corp.
Cardiovascular · 246d
Cleared Oct 05, 1995
CARDIMA, INC. FORERUNNER
K951603 · DQY
Cardima, Inc.
Cardiovascular · 181d
Cleared Oct 04, 1995
1481 T DIGITAL TELEMETRY SYSTEM WITH S-T SEGMENT ANALYSIS OPTION
K951371 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 191d
Cleared Oct 03, 1995
HP M1205A OMNICARE COMPONENT TRANSPORT MONITORING SYSTEM MODEL 24
K950821 · DSI
Hewlett-Packard Co.
Cardiovascular · 222d
Cleared Sep 29, 1995
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
K952328 · DXY
Biotronik, Inc.
Cardiovascular · 134d
Cleared Sep 29, 1995
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
K953417 · DXY
Cook Pacemaker Corp.
Cardiovascular · 113d
Cleared Sep 28, 1995
DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF
K953952 · DXQ
Deroyal Industries, Inc.
Cardiovascular · 37d
Cleared Sep 26, 1995
LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR
K945511 · MPE
Physio-Control Corp.
Cardiovascular · 321d