FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
15769–15792 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 29, 1983
FOGARTY 6MM SOFTJAW CLIP
K832554 · DXC
American Edwards Laboratories
Cardiovascular · 59d
Cleared Sep 29, 1983
SHILEY GAS FILTER
K832704 · KRI
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 29, 1983
CORONARY ANASTOMOSIS MARKING SYSTEM
K832806 · DSY
Biotrac Laboratories
Cardiovascular · 42d
Cleared Sep 29, 1983
FLOW-DIRECTED HEPARIN COATED THERMODIL
K832957 · DYG
Sorensen Research
Cardiovascular · 29d
Cleared Sep 20, 1983
PRE-BYPASS FILTER #EC-PBF SERIES
K832594 · KRJ
Gish Biomedical, Inc.
Cardiovascular · 49d
Cleared Sep 20, 1983
SHILEY 3L CARDF PLUS
K832811 · DTP
Shiley, Inc.
Cardiovascular · 33d
Cleared Sep 12, 1983
BOMED BIOCON
K831421 · DSB
Bomed Medical Mfr., Ltd.
Cardiovascular · 132d
Cleared Sep 12, 1983
BIOFLOW
K831422 · DSB
Bomed Medical Mfr., Ltd.
Cardiovascular · 132d
Cleared Sep 12, 1983
AIR SHIELDS AS-100 MONIORING SYS-AS105
K831430 · DRT
Narco Scientific
Cardiovascular · 132d
Cleared Sep 12, 1983
ANGIO-FLO CONTIN-ARTERIAL FLUSH DEV.
K832058 · KRA
Parke-Davis Co.
Cardiovascular · 77d
Cleared Sep 12, 1983
GASLINE FILTER #GF-10
K832411 · KRI
American Bentley
Cardiovascular · 53d
Cleared Sep 09, 1983
C TEC SERIES 9000 E.C.G. ELECTRODE
K831977 · DRX
Speywood Medical, Ltd.
Cardiovascular · 81d
Cleared Aug 31, 1983
HANCOCK PERICARDIAL PATCH
K830863 · DXZ
Extracorporeal Medical Specialities,...
Cardiovascular · 166d
Cleared Aug 31, 1983
RAPID ATRIAL PACER
K831381 · DTE
Seamed Corp.
Cardiovascular · 125d
Cleared Aug 31, 1983
EMBOLECTOMY CATHETER
K832023 · DXE
Bionomy, Inc.
Cardiovascular · 79d
Cleared Aug 31, 1983
VESSEL DILATOR
K832595 · DWP
Abbott Laboratories
Cardiovascular · 29d
Cleared Aug 24, 1983
PERCUTANEOUS INTRODUCER KIT
K831636 · DQY
Accu-Line
Cardiovascular · 93d
Cleared Aug 16, 1983
IMPLANTABLE PROGRAM. CARDIAC PULSE GEN
K831771 · DXY
Telectronics, Inc.
Cardiovascular · 75d
Cleared Aug 13, 1983
VASCULAR GRAFT/BIFURCATED/FEP-RINGED
K830806 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 152d
Cleared Aug 12, 1983
BIOELECTRICAL IMPEDANCE ANALYZER #101
K830292 · DSB
Rjl Systems, Inc.
Cardiovascular · 197d
Cleared Aug 12, 1983
BLOOD PRESSURE MONITORING KITS,WALRUS
K830754 · DXT
Medical Parameters, Inc.
Cardiovascular · 155d
Cleared Aug 12, 1983
EXTERNAL VALVE FUNCTION BLOCK
K830914 · DRQ
Honeywell, Inc.
Cardiovascular · 141d
Cleared Aug 12, 1983
DISPOS. ABODOMINAL RETRACTING PAD
K831130 · DWF
Product Development Corp.
Cardiovascular · 128d
Cleared Aug 12, 1983
PACELINE PATIENT TRANSMITTER MODEL 324
K831443 · DXH
Pacesetter Systems
Cardiovascular · 99d