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
7009–7032 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 15, 2006
8F SHERPA NX GUIDE CATHETER
K060418 · DQY
Medtronic Vascular
Cardiovascular · 26d
Cleared Mar 15, 2006
MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB
K052555 · DTQ
Rand S.R.L.
Cardiovascular · 180d
Cleared Mar 14, 2006
IDEAL LIFE BP-MANAGER, MODEL BPM 0001
K060504 · DXN
Ideal Life, Inc.
Cardiovascular · 15d
Cleared Mar 13, 2006
PVS 2000 SYNCHRO2 GUIDEWIRE
K053268 · DQX
Boston Scientific - Precision Vascular
Cardiovascular · 110d
Cleared Mar 10, 2006
COMPASS COMPRESSION ASSIST HANDLE
K053398 · DXC
Semler Technologies, Inc. Dba
Cardiovascular · 94d
Cleared Mar 09, 2006
LYSUS INFUSION SYSTEM
K060422 · QEY
Ekos Corp.
Cardiovascular · 20d
Cleared Mar 09, 2006
QUICKCAT EXTRACTION CATHETER
K060092 · QEZ
Kensey Nash Corp.
Cardiovascular · 56d
Cleared Mar 09, 2006
MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
K053645 · DWJ
Arizant Healthcare, Inc.
Cardiovascular · 69d
Cleared Mar 09, 2006
NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE
K053194 · DQK
Biosense Webster, Inc.
Cardiovascular · 114d
Cleared Mar 08, 2006
ACTIVECARE ++ SYSTEM
K060146 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 48d
Cleared Mar 08, 2006
RTT DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL RTW-8010A
K060077 · DXN
Real Tone Technology Corp.
Cardiovascular · 57d
Cleared Mar 08, 2006
TECHDEVICE GUIDEWIRE
K053251 · DQX
Techdevice Corporation
Cardiovascular · 107d
Cleared Mar 08, 2006
CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145,...
K053217 · DQY
St Jude Medical
Cardiovascular · 111d
Cleared Mar 08, 2006
DP240 240 HOUR DOPPLER PROBE
K052989 · DPT
Deltex Medical
Cardiovascular · 135d
Cleared Mar 08, 2006
THEROX INFUSION CATHETER, MODEL INCA-1
K052637 · DQO
Therox, Inc.
Cardiovascular · 163d
Cleared Mar 06, 2006
MODIFICATION TO MIRA-FLEX 18 MICROCATHETER
K060224 · KRA
Cook Incorporated
Cardiovascular · 35d
Cleared Mar 03, 2006
ACUITY STEERABLE STYLET ACCESSORY
K053019 · DRB
Guidant Corporation
Cardiovascular · 128d
Cleared Mar 02, 2006
INNOCOR
K051907 · DQK
Innovision A/S
Cardiovascular · 231d
Cleared Feb 28, 2006
PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC...
K053609 · DQE
Edwards Lifesciences, LLC
Cardiovascular · 63d
Cleared Feb 28, 2006
KD-788 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
K052450 · DXN
Kodon(Tianjin)Electronic&Electrical...
Cardiovascular · 174d
Cleared Feb 24, 2006
REPROCESSED COMPRESSION SLEEVES
K060049 · JOW
Alliance Medical Corp.
Cardiovascular · 49d
Cleared Feb 24, 2006
CPS DIRECT SL OUTER CATHETER
K053277 · DQY
St Jude Medical
Cardiovascular · 93d
Cleared Feb 24, 2006
TECHDEVICE OCCLUSION BALLOON CATHETER
K051137 · MJN
Techdevice Corporation
Cardiovascular · 296d
Cleared Feb 24, 2006
GERATHERM SOS-RESCUE BLANKET
K051097 · DWJ
Rg Ent., Inc.
Cardiovascular · 301d