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
14905–14928 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 21, 1985
MULTICOR S, MODELS 330A/331A
K851420 · DXY
Cordis Corp.
Cardiovascular · 73d
Cleared Jun 20, 1985
GV MEDICAL, INC. LASTAC BALLOON DILATATION CATHETE
K851080 · LIT
G V Medical, Inc.
Cardiovascular · 94d
Cleared Jun 20, 1985
MEDTRONIC MODEL 6404
K851948 · DYG
Medtronic Vascular
Cardiovascular · 48d
Cleared Jun 20, 1985
SERIES 7000/HOLTER RECORDER
K851971 · DSH
Pfizer, Inc.
Cardiovascular · 44d
Cleared Jun 20, 1985
LIGHT REFLECTION RHEOGRAPHY
K852378 · DSB
Hemodynamics, Inc.
Cardiovascular · 15d
Cleared Jun 19, 1985
POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER
K850015 · DXE
Polymed Laboratories
Cardiovascular · 168d
Cleared Jun 19, 1985
MDI 2000 - PULSE GENERATOR
K850791 · DRO
Micromedical Devices, Inc.
Cardiovascular · 113d
Cleared Jun 19, 1985
TELEFLEX MEDICAL INTRODUCER NEEDLE
K851140 · DWS
Teleflexmedical, Inc.
Cardiovascular · 90d
Cleared Jun 19, 1985
COBE GAS FILTER
K851289 · KRI
Cobe Laboratories, Inc.
Cardiovascular · 79d
Cleared Jun 19, 1985
MODIFICATIONS TO ACS CORONARY GUIDING CATHETER W/T
K851574 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 63d
Cleared Jun 19, 1985
CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER
K851613 · KFM
Centrimed Corp.
Cardiovascular · 61d
Cleared Jun 19, 1985
CENTRIMED SYSTEM 1 W/24 VOLT BATTERY POWER SUPPLY
K851614 · DTQ
Centrimed Corp.
Cardiovascular · 61d
Cleared Jun 19, 1985
CENTRIMED SYSTEM 1 W/MANUAL PUMP DRIVE
K851615 · DTQ
Centrimed Corp.
Cardiovascular · 61d
Cleared Jun 19, 1985
BIO MEDICUS BIO PUMP MODEL BP-90
K851855 · KFM
Bio Medicus, Inc.
Cardiovascular · 54d
Cleared Jun 19, 1985
MEDTRONIC 5064
K851890 · DTD
Medtronic Vascular
Cardiovascular · 50d
Cleared Jun 19, 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852123 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 35d
Cleared Jun 18, 1985
CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS
K844360 · DXY
Cordis Corp.
Cardiovascular · 217d
Cleared Jun 14, 1985
AMBULATORY PH RECORDING DEVICE
K842349 · DSH
Clinical Data Instruments, Inc.
Cardiovascular · 364d
Cleared Jun 13, 1985
SHARP DIGITAL BP MONITOR MB-371H
K850830 · DXN
Sharp Electronics Corp.
Cardiovascular · 127d
Cleared Jun 11, 1985
DOSIMETRIC RELEASE OF RAD. TUBING PAC
K833047 · DWF
American Bentley
Cardiovascular · 644d
Cleared Jun 11, 1985
DISPOS. PRESSURE KIT 1295K SERIES
K843273 · DRS
Hewlett-Packard Co.
Cardiovascular · 295d
Cleared Jun 11, 1985
CORDIS ELECTROPHYSIOLOGY STIMULATOR
K844815 · JOQ
Cordis Corp.
Cardiovascular · 182d
Cleared Jun 11, 1985
STANICOR GAMMA 333B/334A
K851416 · DXY
Cordis Corp.
Cardiovascular · 63d
Cleared Jun 11, 1985
MULTICOR GAMMA MODELS 336/337
K851417 · DXY
Cordis Corp.
Cardiovascular · 63d