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
8017–8040 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 29, 2003
CARECOMPANION PATIENT STATION & NURSE STATION
K022274 · DRG
Neptec Design Group, Ltd.
Cardiovascular · 318d
Cleared May 29, 2003
PACEART SYSTEM
K024278 · DPS
Medtronic Vascular
Cardiovascular · 157d
Cleared May 29, 2003
THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20
K031481 · MHX
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 17d
Cleared May 28, 2003
IN-VISION IMAGING SYSTEM
K031148 · DXK
Jomed, Inc.
Cardiovascular · 48d
Cleared May 27, 2003
COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM
K023937 · DYB
Cook Vascular, Inc.
Cardiovascular · 182d
Cleared May 27, 2003
REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM
K031610 · MCW
Rex Medical
Cardiovascular · 5d
Cleared May 23, 2003
AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR)
K030230 · DXN
Avita Corporation
Cardiovascular · 121d
Cleared May 23, 2003
CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221
K030398 · DQR
Cardiacassist, Inc.
Cardiovascular · 106d
Cleared May 22, 2003
MODEL 5071 MYOCARDIAL PACING LEAD
K031274 · DTB
Medtronic Vascular
Cardiovascular · 30d
Cleared May 22, 2003
EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE,...
K031518 · DWF
Medtronic Vascular
Cardiovascular · 7d
Cleared May 21, 2003
MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS
K030589 · DQY
NuMED, Inc.
Cardiovascular · 85d
Cleared May 21, 2003
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
K030617 · DQX
Boston Scientific Scimed, Inc.
Cardiovascular · 84d
Cleared May 21, 2003
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE
K030812 · MHX
Datex-Ohmeda
Cardiovascular · 68d
Cleared May 20, 2003
IS-1 HEMOSTASIS VALVE, MODEL 6799
K031398 · DTL
Guidant Corp.
Cardiovascular · 15d
Cleared May 16, 2003
MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
K031210 · DTB
Metronic, Inc.
Cardiovascular · 29d
Cleared May 14, 2003
CAPIOX CARDIOTOMY RESERVOIR
K030505 · DPW
Terumo Cardiovascular Systems Corp.
Cardiovascular · 84d
Cleared May 14, 2003
HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE...
K030549 · DQX
Guidcorp
Cardiovascular · 82d
Cleared May 14, 2003
JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS...
K031277 · DQX
Jomed, Inc.
Cardiovascular · 22d
Cleared May 14, 2003
IBC FLOPUMP WITH GBS COATING
K031300 · KFM
Gish Biomedical, Inc.
Cardiovascular · 20d
Cleared May 13, 2003
DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000
K022834 · MHX
Ge Medical Systems Information...
Cardiovascular · 260d
Cleared May 13, 2003
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE
K031037 · DWF
Medtronic Perfusion Systems
Cardiovascular · 42d
Cleared May 09, 2003
HERO
K021230 · DPS
Medical Decision Networks
Cardiovascular · 386d
Cleared May 09, 2003
PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2
K023338 · DXN
Fms, Finapres Medical Systems BV
Cardiovascular · 214d
Cleared May 09, 2003
DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE),...
K030417 · LDD
Philips Medical Systems
Cardiovascular · 88d