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
9409–9432 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 01, 1999
ADVANTA GRAFT (<6MM)
K992958 · DYF
Atrium Medical Corp.
Cardiovascular · 29d
Cleared Oct 01, 1999
ADVANTA GRAFT (>6MM)
K992960 · DSY
Atrium Medical Corp.
Cardiovascular · 29d
Cleared Sep 29, 1999
WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
K991540 · LIT
AngioDynamics, Inc.
Cardiovascular · 149d
Cleared Sep 29, 1999
KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325
K992079 · JOW
The Kendall Company, L.P.
Cardiovascular · 100d
Cleared Sep 29, 1999
INTRAMAX ITI GUIDE CATHETER
K992622 · DQY
Intratherapeutics, Inc.
Cardiovascular · 55d
Cleared Sep 29, 1999
CARTO EP NAVIGATION SYSTEM
K992968 · DQK
Biosense Webster, Inc.
Cardiovascular · 26d
Cleared Sep 23, 1999
AGILITY STEERABLE GUIDEWIRE
K991646 · DQX
Cordis Neurovascular, Inc.
Cardiovascular · 133d
Cleared Sep 20, 1999
STATVIEW SYSTEM
K990378 · MSX
Data Critical Corp.
Cardiovascular · 224d
Cleared Sep 20, 1999
HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010
K992559 · DTZ
Jostra Bentley
Cardiovascular · 52d
Cleared Sep 17, 1999
CARDIOPHONICS 1000 MEMORY MONITOR
K992772 · DXH
Rlt Medical Assoc., Inc.
Cardiovascular · 30d
Cleared Sep 16, 1999
BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM
K983717 · DXN
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 330d
Cleared Sep 16, 1999
ECHOFLOW DOPPLER BLOOD VELOCITY METER
K990642 · JOP
Echocath, Inc.
Cardiovascular · 202d
Cleared Sep 15, 1999
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
K983196 · DRO
Tz Medical, Inc.
Cardiovascular · 369d
Cleared Sep 15, 1999
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT...
K983232 · DRO
Tz Medical, Inc.
Cardiovascular · 366d
Cleared Sep 15, 1999
CORDIS EXTREME PTA BALLOON CATHETER
K992825 · LIT
Cordis Corp.
Cardiovascular · 23d
Cleared Sep 15, 1999
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE...
K992910 · DTZ
Medtronic Vascular
Cardiovascular · 16d
Cleared Sep 14, 1999
MADTRONIC DLP ARTERIAL CANNULAE
K991066 · DWF
Medtronic Vascular
Cardiovascular · 167d
Cleared Sep 09, 1999
MEDTRONIC GT2 FUSION GUIDE WIRES
K992237 · DQX
Medtronic Vascular
Cardiovascular · 69d
Cleared Sep 08, 1999
PTFE RINGED GORE-TEX VASCULAR GRAFT
K991683 · DYF
W.L. Gore & Associates, Inc.
Cardiovascular · 114d
Cleared Sep 08, 1999
SLIMLINE SURGICAL CLAMP
K992640 · DXC
Minumys Surgical, Inc.
Cardiovascular · 33d
Cleared Sep 03, 1999
MODIFICATION OF NOGA
K990494 · DQK
Biosense, Inc.
Cardiovascular · 198d
Cleared Sep 03, 1999
ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
K990762 · MKJ
Zoll Medical Corp
Cardiovascular · 179d
Cleared Sep 03, 1999
LIFEPAK 12 BIPHASIC
K991910 · MKJ
Physio-Control Corp.
Cardiovascular · 88d
Cleared Sep 03, 1999
CAPIOX SX10 HARDSHELL RESEVOIR
K991973 · DTN
Terumo Medical Corp.
Cardiovascular · 84d