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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
14977–15000 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 15, 1985
PROGRAMALITH III 240 PULSE GENERATOR
K850464 · DXY
Pacesetter Systems
Cardiovascular · 97d
Cleared May 15, 1985
R-1000 ECG RECEIVER
K851123 · DXH
Brentwood Instruments, Inc.
Cardiovascular · 57d
Cleared May 15, 1985
T-1000 ECG TRANSMITTER
K851124 · DXH
Brentwood Instruments, Inc.
Cardiovascular · 57d
Cleared May 15, 1985
THUMPER CARDIOPULMONARY RESUSCITATOR 1005
K851139 · DRM
Michigan Instruments, Inc.
Cardiovascular · 55d
Cleared May 15, 1985
OHMEDA MODEL 0001/0003 RECORDER
K851274 · DSF
Ohmeda Medical
Cardiovascular · 44d
Cleared May 15, 1985
QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR
K851302 · DRG
Quinton, Inc.
Cardiovascular · 44d
Cleared May 01, 1985
CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER)
K844969 · DTC
Cordis Corp.
Cardiovascular · 128d
Cleared Apr 29, 1985
POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE
K844803 · DTP
Electromedics, Inc.
Cardiovascular · 139d
Cleared Apr 29, 1985
INTRACARDIAC SUMP 12010
K850385 · DWF
Dlp, Inc.
Cardiovascular · 87d
Cleared Apr 29, 1985
NONINVASIVE ELECTRONIC DIGITAL BP MONITOR EBM-1050
K850476 · DXN
Unisonic Products Corp.
Cardiovascular · 90d
Cleared Apr 29, 1985
NONINVASIVE ELECTRONIC DIGITAL BP MONITOR EBM-2050
K850477 · DXN
Unisonic Products Corp.
Cardiovascular · 90d
Cleared Apr 25, 1985
CARDIOVIT CS-6 ECG-RECORDER
K850702 · DPS
Schiller AG
Cardiovascular · 63d
Cleared Apr 25, 1985
HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR
K850879 · DSK
Mennen Medical, Inc.
Cardiovascular · 52d
Cleared Apr 25, 1985
HORIZON 1000 CARDIAC MONITOR
K850880 · DRT
Mennen Medical, Inc.
Cardiovascular · 52d
Cleared Apr 24, 1985
LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR
K850394 · DWS
Vascutech, Inc.
Cardiovascular · 82d
Cleared Apr 19, 1985
TP 1
K844483 · KRG
Vitatron Medical BV
Cardiovascular · 151d
Cleared Apr 19, 1985
CERYX6, 611, CERYX 3 311 & CERYX 1 111
K844485 · KRG
Vitatron Medical BV
Cardiovascular · 151d
Cleared Apr 19, 1985
FC-700 DEFIBRILLATOR
K850618 · LDD
Fukuda Denshi USA, Inc.
Cardiovascular · 63d
Cleared Apr 19, 1985
OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE
K850623 · DTB
Oscor Medical Corp.
Cardiovascular · 59d
Cleared Apr 19, 1985
HDC SILCATH SUBCLAVIAN CATHETER PERCUTANEOUS INSER
K851078 · DYB
Hdc Corp.
Cardiovascular · 32d
Cleared Apr 19, 1985
PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD
K851145 · DTD
Pacesetter Systems
Cardiovascular · 29d
Cleared Apr 19, 1985
NUMED BALLOON PACING CATHETER
K851246 · LDF
NuMED, Inc.
Cardiovascular · 25d
Cleared Apr 19, 1985
AMENDMENT LIFEPAK 200, NPN 046
K851247 · DRO
Physio-Control Corp.
Cardiovascular · 43d
Cleared Apr 19, 1985
AMENDMENT LIFEPAK 100, NPN 045
K851248 · DRO
Physio-Control Corp.
Cardiovascular · 43d