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
7297–7320 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 05, 2005
SKIPPER AND SKIPPER RACE GUIDEWIRE
K050756 · DQX
Invatec Innovative Technologies, S.R.L.
Cardiovascular · 43d
Cleared May 05, 2005
ECC.O SYSTEM
K050890 · KFM
Dideco S.R.L.
Cardiovascular · 27d
Cleared May 04, 2005
WINDSURFER
K050561 · DQK
Medcon , Ltd.
Cardiovascular · 62d
Cleared May 04, 2005
CARDIOVIT AT-10PLUS
K050686 · DPS
Schiller AG
Cardiovascular · 49d
Cleared May 03, 2005
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
K050605 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 54d
Cleared May 02, 2005
PREMERE DELIVERY SHEATH, MODEL PDS
K043084 · DYB
Velocimed, Inc.
Cardiovascular · 175d
Cleared Apr 29, 2005
LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE
K043604 · DQK
Vivometrics, Inc.
Cardiovascular · 121d
Cleared Apr 29, 2005
DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS
K050974 · DRQ
Draeger Medical Systems, Inc.
Cardiovascular · 11d
Cleared Apr 28, 2005
ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER
K050794 · QEZ
Possis Medical, Inc.
Cardiovascular · 30d
Cleared Apr 26, 2005
MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1
K043380 · DPS
Monebo Technologies, Inc.
Cardiovascular · 139d
Cleared Apr 22, 2005
PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70...
K050762 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 29d
Cleared Apr 21, 2005
MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822
K043531 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 121d
Cleared Apr 18, 2005
DOLPHIN INFLATION DEVICE
K042449 · MAV
Sedat S.A.
Cardiovascular · 221d
Cleared Apr 18, 2005
HYPERTRANSIT INFUSION CATHETER
K043538 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 117d
Cleared Apr 13, 2005
RELIANT STENT GRAFT BALLOON CATHETER
K050038 · DQY
Medtronic Endovascular Innovations
Cardiovascular · 96d
Cleared Apr 13, 2005
TELEREHAD 2004
K050778 · DRG
Scottcare
Cardiovascular · 16d
Cleared Apr 08, 2005
BLOOD-PRESSURE METER, BPW120
K050083 · DXN
Idt Technology Limited
Cardiovascular · 85d
Cleared Apr 07, 2005
ZOLL E SERIES DEFIBRILLATOR
K042007 · MKJ
Zoll Medical Corp
Cardiovascular · 255d
Cleared Apr 07, 2005
HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM
K050225 · DQK
Cambridge Heart, Inc.
Cardiovascular · 65d
Cleared Apr 07, 2005
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT
K050711 · DXN
Health & Life Co., Ltd.
Cardiovascular · 20d
Cleared Apr 07, 2005
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS
K050714 · DXN
Health & Life Co., Ltd.
Cardiovascular · 20d
Cleared Apr 05, 2005
OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N
K042505 · DXN
Omron Healthcare, Inc.
Cardiovascular · 202d
Cleared Apr 05, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M
K042506 · DXN
Omron Healthcare, Inc.
Cardiovascular · 202d
Cleared Apr 05, 2005
HL 200 ELECTRONIC STETHOSCOPE
K050169 · DQD
Health & Life Co., Ltd.
Cardiovascular · 69d