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
8833–8856 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 02, 2001
SYNETEC
K002817 · DQK
Ela Medical, Inc.
Cardiovascular · 233d
Cleared May 02, 2001
PTA-OS SIZING BALLOON, MODEL 360
K003320 · MJN
NuMED, Inc.
Cardiovascular · 190d
Cleared May 02, 2001
HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A
K003819 · MKJ
Agilent Technologies, Inc.
Cardiovascular · 142d
Cleared May 02, 2001
SIII ALARM AMPLIFIER
K011088 · DTQ
Stockert Instrumente GmbH
Cardiovascular · 22d
Cleared May 01, 2001
SPHYGMOCOR MX MODEL SCOR-MX
K002742 · DSK
Pwv Medical Pty, Lt.
Cardiovascular · 242d
Cleared May 01, 2001
AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154
K011093 · MHX
Agilent Technologies, Inc.
Cardiovascular · 21d
Cleared Apr 27, 2001
GRAFT MARKER RING
K001915 · MAB
T. Korossurgical Instruments Corp.
Cardiovascular · 308d
Cleared Apr 26, 2001
ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
K002627 · DXE
Atrium Medical Corp.
Cardiovascular · 246d
Cleared Apr 26, 2001
EMBOL-X INTRODUCER, MODEL CF00200
K002973 · DYB
Embol-X, Inc.
Cardiovascular · 216d
Cleared Apr 26, 2001
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000...
K004046 · DTP
Cobe Cardiovascular, Inc.
Cardiovascular · 118d
Cleared Apr 26, 2001
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
K010955 · DPS
Boston Medical Technologies, Inc.
Cardiovascular · 27d
Cleared Apr 20, 2001
ORIGEN BLADDER HOLDER
K003145 · DWC
Origen Biomedical, Inc.
Cardiovascular · 192d
Cleared Apr 20, 2001
NUMED HIGH PRESSURE PTA CATHETERS
K010880 · DQY
NuMED, Inc.
Cardiovascular · 28d
Cleared Apr 18, 2001
ILT DEFLECTING CATHETER, MODEL C114ND1
K010531 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 54d
Cleared Apr 18, 2001
AB CARDIETTE START 200 HV
K010822 · DPS
H&C Medical Devices Spa
Cardiovascular · 30d
Cleared Apr 18, 2001
GUIDER SOFTIP GUIDING CATHETER XF 5F
K010853 · DQY
Boston Scientific, Target
Cardiovascular · 28d
Cleared Apr 12, 2001
CH 2000 CARDIAC DIAGNOSTIC SYSTEM
K010756 · DQK
Cambridge Heart, Inc.
Cardiovascular · 30d
Cleared Apr 12, 2001
HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS
K010758 · DPS
Cambridge Heart, Inc.
Cardiovascular · 30d
Cleared Apr 10, 2001
SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE
K003731 · DYB
Thomas Medical Products, Inc.
Cardiovascular · 127d
Cleared Apr 09, 2001
ICG MODULE
K010164 · DSB
General Electric Medical Systems...
Cardiovascular · 81d
Cleared Apr 05, 2001
SENTECH MEDICAL EXPRESS COMPRESSION SYSTEM (P/N SM800)
K003701 · JOW
Sentech Medical Systems, Inc.
Cardiovascular · 125d
Cleared Apr 05, 2001
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
K010906 · DRB
Medtronic Vascular
Cardiovascular · 10d
Cleared Apr 05, 2001
ALARMVIEW WIRELESS DATA NETWORK SYSTEM
K010912 · MSX
Data Critical Corp.
Cardiovascular · 9d
Cleared Apr 04, 2001
GUIDANT AXIUS CORONARY SHUNT
K010117 · DXC
Cardiothoracic Systems, Inc.
Cardiovascular · 78d