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
12601–12624 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 03, 1990
CARDIAC OUTPUT COMPUTER, MODEL COM-3
K896930 · DXG
Baxter Healthcare Corp
Cardiovascular · 204d
Cleared Jul 03, 1990
CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512
K900246 · DSI
Ppg Industries, Inc.
Cardiovascular · 167d
Cleared Jul 03, 1990
MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.
K901535 · DXY
Medtronic Vascular
Cardiovascular · 92d
Cleared Jul 03, 1990
SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.
K901624 · DTZ
Shiley, Inc.
Cardiovascular · 85d
Cleared Jul 03, 1990
PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS
K901682 · DSY
Pioneering Technologies, Inc.
Cardiovascular · 84d
Cleared Jul 03, 1990
MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY
K901815 · DRE
Pioneering Technologies, Inc.
Cardiovascular · 71d
Cleared Jul 03, 1990
MINIX, MINIX ST, NEW IC: L74
K902134 · DXY
Medtronic Vascular
Cardiovascular · 54d
Cleared Jun 29, 1990
BIOPSY FORCEPS
K901300 · DWZ
Portlyn Corp.
Cardiovascular · 101d
Cleared Jun 29, 1990
CUFF, BLOOD PRESSURE
K902132 · DXQ
Buffalo Medical Specialties Mfg., Inc.
Cardiovascular · 50d
Cleared Jun 28, 1990
SCIMED CORONARY GUIDING CATHETER
K895437 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 293d
Cleared Jun 28, 1990
PACEMAKER PATIENT ADAPTOR MODULE (PPAM)
K900213 · DSB
Bomed Medical Mfg., Ltd.
Cardiovascular · 162d
Cleared Jun 28, 1990
SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM
K900319 · DSI
Siemens Medical Electronics
Cardiovascular · 156d
Cleared Jun 28, 1990
BIO-MEDICUS BIO CONSOLE MODELS 540 A B C
K901584 · DWA
Bio Medicus, Inc.
Cardiovascular · 85d
Cleared Jun 28, 1990
MODIFIED IVT PERIPHERAL ATHERECTOMY
K901767 · LIT
Intensive Technology, Inc.
Cardiovascular · 72d
Cleared Jun 26, 1990
NAMIC PTCA Y-ADAPTOR
K900652 · DTL
North American Instrument Corp.
Cardiovascular · 137d
Cleared Jun 26, 1990
DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER
K901391 · DYB
Datascope Corp.
Cardiovascular · 92d
Cleared Jun 26, 1990
MONITOR, MODEL 2817
K902334 · DXJ
Esaote Biomedica Spa
Cardiovascular · 33d
Cleared Jun 25, 1990
SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS
K900512 · DTD
Pacesetter Systems
Cardiovascular · 143d
Cleared Jun 22, 1990
PACEMATE FLOW DIRECTED THERMAL DILUTION CATHETER
K900317 · KRB
Elecath
Cardiovascular · 150d
Cleared Jun 22, 1990
GRI LASERGRAPH(TM) ECG PAPER
K902586 · DSF
Gri Medical Products, Inc.
Cardiovascular · 10d
Cleared Jun 21, 1990
PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC.
K896964 · DSY
Medtronic Vascular
Cardiovascular · 188d
Cleared Jun 21, 1990
DATASCOPE SLIDEWIRE(TM)
K901347 · DQX
Datascope Corp.
Cardiovascular · 90d
Cleared Jun 19, 1990
COLORADO COLOR IMAGING RECORDER
K902230 · DSF
Honeywell, Inc.
Cardiovascular · 33d
Cleared Jun 12, 1990
ACS ADVANCED CONCEPT GUIDE WIRE
K900386 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 134d