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
15145–15168 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 06, 1985
SURGICAL MODULE 7000 ECG
K840869 · DPS
Marquette Electronics, Inc.
Cardiovascular · 345d
Cleared Feb 01, 1985
MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC
K840037 · DSP
Smec, Inc.
Cardiovascular · 393d
Cleared Feb 01, 1985
ARRHYTHMIA SYSTEM AC-11
K841084 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 325d
Cleared Feb 01, 1985
VARIABLE PRIME COBE MEMBRANE LUNG
K842908 · DTZ
Cobe Laboratories, Inc.
Cardiovascular · 192d
Cleared Feb 01, 1985
CARDIAC COMPUTER SP1445
K843555 · DXG
Gould, Inc.
Cardiovascular · 144d
Cleared Feb 01, 1985
SEAMED 4000
K843777 · DTE
Seamed Corp.
Cardiovascular · 129d
Cleared Feb 01, 1985
SEAMED MODEL 6000
K843807 · DTE
Seamed Corp.
Cardiovascular · 127d
Cleared Feb 01, 1985
PULSE-AID DEVICE
K843977 · LIX
James J. Lally
Cardiovascular · 119d
Cleared Feb 01, 1985
LARIAT CATHETER
K844598 · DQO
Mallinckrodt Critical Care
Cardiovascular · 67d
Cleared Feb 01, 1985
MEDTRONIC MODEL 6912
K844687 · DTD
Medtronic Vascular
Cardiovascular · 60d
Cleared Feb 01, 1985
SPACELABS SERIES 600 PATIENT MONITORS
K844888 · DRT
Spacelabs, Inc.
Cardiovascular · 46d
Cleared Feb 01, 1985
CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM
K850136 · DSI
Cardio Data
Cardiovascular · 18d
Cleared Jan 31, 1985
COLOR DOPPLER 880
K843643 · DXK
Irex Corp.
Cardiovascular · 136d
Cleared Jan 29, 1985
PERRY SUTURING SET W/ANESTHETIC
K844610
Perry, Div.
Cardiovascular · 63d
Cleared Jan 24, 1985
CARDIOVIT CV-3
K841254 · DPS
Schiller AG
Cardiovascular · 304d
Cleared Jan 24, 1985
GORE-TEX TUNNELER
K844584 · DWS
W.L. Gore & Associates, Inc.
Cardiovascular · 62d
Cleared Jan 24, 1985
PACE AID MODEL 53
K844811 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 44d
Cleared Jan 23, 1985
MX2 ELECTRONIC STETHOSCOPE
K842705 · DQD
Medmax, Inc.
Cardiovascular · 196d
Cleared Jan 23, 1985
MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER
K843969 · DXO
Gould, Inc.
Cardiovascular · 104d
Cleared Jan 23, 1985
CARDIO IV/GXT STRESS TESTING SYSTEM
K844744 · DPS
Intl. Medical, Inc.
Cardiovascular · 49d
Cleared Jan 22, 1985
DR-2C
K844650 · DXJ
General Devices
Cardiovascular · 54d
Cleared Jan 22, 1985
HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2
K850070 · DXN
Healthcheck Corp.
Cardiovascular · 18d
Cleared Jan 18, 1985
TRANSVENOUS TINED VENTRICULAR/ATRIAL
K842031 · DTB
Medtronic Vascular
Cardiovascular · 245d
Cleared Jan 18, 1985
MODELS 4012/4512 TRANSVENOUS TINED-
K842032 · DTB
Medtronic Vascular
Cardiovascular · 245d