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
12793–12816 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 29, 1990
GENESIS III, (MOD. 7003/7004)
K894370 · DXK
Biosound, Inc.
Cardiovascular · 199d
Cleared Jan 26, 1990
SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283
K882955 · DXN
Kontron Instruments, Inc.
Cardiovascular · 561d
Cleared Jan 26, 1990
EXPANSION OF THE CORDIS PTA DILATATION CATHETER
K894899 · LIT
Cordis Corp.
Cardiovascular · 178d
Cleared Jan 26, 1990
WR3500 AND WR3600 SERIES RECORDERS
K894922 · DSF
Western Graphtec
Cardiovascular · 177d
Cleared Jan 26, 1990
TYPE 9541 RECORDER, PAPER CHART
K895111 · DSF
S & W Medico Teknik
Cardiovascular · 176d
Cleared Jan 26, 1990
AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED
K895266 · DSI
Biosensor Corp.
Cardiovascular · 156d
Cleared Jan 26, 1990
MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER
K895525 · DRL
Matrix Medica, Inc.
Cardiovascular · 136d
Cleared Jan 26, 1990
LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER
K895533 · LDD
Matrix Medica, Inc.
Cardiovascular · 135d
Cleared Jan 26, 1990
JOBST ATHROMBIC PUMP(R) SYSTEM 2000
K895732 · JOW
Jobst Institute, Inc.
Cardiovascular · 122d
Cleared Jan 26, 1990
HPD TUBING CONNECTORS
K895795 · DTL
Hpd Medical, Inc.
Cardiovascular · 121d
Cleared Jan 26, 1990
AMBULATORY CARDIAC MONITOR
K896064 · DPS
Monitech, Inc.
Cardiovascular · 100d
Cleared Jan 26, 1990
SFA MODULE
K896528 · DXG
Life Sciences Manufacturing, Inc.
Cardiovascular · 71d
Cleared Jan 26, 1990
MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR
K896809 · DXY
Medtronic Vascular
Cardiovascular · 53d
Cleared Jan 26, 1990
MODIFIED HEARTSTART 2000 DEFIBRILLATION ELECTRODE
K900169 · LDD
Laerdal Mfg. Corp.
Cardiovascular · 14d
Cleared Jan 24, 1990
MILLAR MIKRO-TIP DOPPLER CATHETER
K896264 · JOP
Millar Instruments, Inc.
Cardiovascular · 85d
Cleared Jan 24, 1990
MODEL EC4542G MINIATURE
K896352 · DTE
Pace Medical
Cardiovascular · 79d
Cleared Jan 24, 1990
MODIFIED ANGIOGRAPHIC CATHETER
K896690 · DQO
Novoste Corp.
Cardiovascular · 57d
Cleared Jan 19, 1990
NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW.
K894631 · DPW
Nihon Kohden America, Inc.
Cardiovascular · 179d
Cleared Jan 19, 1990
BALLOON DILATATION CATHETER
K894944 · LIT
Peripheral Systems Group
Cardiovascular · 169d
Cleared Jan 19, 1990
GUIDING CATHETER
K895146 · DQO
Peripheral Systems Group
Cardiovascular · 150d
Cleared Jan 19, 1990
B-D ANGIOGRAPHIC CONTROL SYRINGE
K895318 · DXT
Bd Becton Dickinson Vacutainer...
Cardiovascular · 143d
Cleared Jan 19, 1990
MEDISEAL SUCTION CANISTER
K895427 · DWD
Deroyal Industries, Inc.
Cardiovascular · 136d
Cleared Jan 19, 1990
CARRY-ALL EKG TRANSTELEPHONIC TRANSMITTER
K896002 · DXH
Instromedix, Inc.
Cardiovascular · 98d
Cleared Jan 19, 1990
MODIFIED DR-2C/PMC 100
K896153 · DSH
General Devices
Cardiovascular · 87d