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
15169–15192 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 18, 1985
EPICARDIAL, UNIPOLAR LEAD 4951
K842065 · DTD
Medtronic Vascular
Cardiovascular · 241d
Cleared Jan 18, 1985
TRANSVENOUS TINED VENTRICULAR LEAD
K842145 · DTD
Medtronic Vascular
Cardiovascular · 233d
Cleared Jan 18, 1985
PATIENT MONITOR 78354A
K842236 · DRT
Hewlett-Packard Co.
Cardiovascular · 227d
Cleared Jan 18, 1985
MODEL 503FB
K842759 · LOS
Atrix
Cardiovascular · 186d
Cleared Jan 18, 1985
CARDIOPAC DEFIBRILLATOR 444
K844103 · LDD
Birtcher Corp.
Cardiovascular · 87d
Cleared Jan 18, 1985
ARRHYTHMIA CENTRAL-OGP-7201
K844911 · DRT
Nihon Kohden America, Inc.
Cardiovascular · 31d
Cleared Jan 15, 1985
RIGHT VENTRICULAR EJECTION FRACTION-
K842105 · DXG
American Edwards Laboratories
Cardiovascular · 235d
Cleared Jan 14, 1985
SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER
K841401 · DXG
American Edwards Laboratories
Cardiovascular · 286d
Cleared Jan 14, 1985
SHILEY HARDSHELL VENOUS RESERVOIR W/INT
K843232 · DTN
Shiley, Inc.
Cardiovascular · 150d
Cleared Jan 14, 1985
NUMED BALLOON PACING CATHETER
K843290 · LDF
NuMED, Inc.
Cardiovascular · 146d
Cleared Jan 14, 1985
VENOUS RESERVOIR VRS-XXX SERIES
K844229 · DTN
Gish Biomedical, Inc.
Cardiovascular · 74d
Cleared Jan 14, 1985
CARDIOTOMY RESERVOIR BCR-2000
K844366 · DTN
American Bentley
Cardiovascular · 62d
Cleared Jan 14, 1985
CARDIOTOMY RESERVOIR W/FILTER BCR-2500
K844367 · DTN
American Bentley
Cardiovascular · 62d
Cleared Jan 14, 1985
M/D4 W/CHARGER (CARDIOPAC 3M11)
K844447 · LDD
Datascope Corp.
Cardiovascular · 59d
Cleared Jan 14, 1985
INFANT LIMB ELECTRODE
K844632 · DRX
Sentry Medical Products, Inc.
Cardiovascular · 48d
Cleared Jan 14, 1985
HOLTER CURA-LITE RECORDER
K844977 · DSH
Cardionostics, Inc.
Cardiovascular · 19d
Cleared Jan 10, 1985
HORIZON ECG SYSTEM
K823844 · DSI
Beckman Instruments, Inc.
Cardiovascular · 751d
Cleared Jan 10, 1985
MULTILITH PULSE GENERATORS, 1141 & 2141
K842193 · DXY
Ela Medical, Inc.
Cardiovascular · 220d
Cleared Jan 10, 1985
VIVALITH II 301 PULSE GENERATOR
K844334 · DXY
Pacesetter Systems
Cardiovascular · 64d
Cleared Jan 10, 1985
MODEL 78210A TELEMETRY TRANSMITTER
K844376 · DRG
Hewlett-Packard Co.
Cardiovascular · 58d
Cleared Jan 10, 1985
FUKUDA DENSHI MODEL FCP-220
K844470 · DPS
Brentwood Instruments, Inc.
Cardiovascular · 52d
Cleared Jan 10, 1985
MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN
K844959 · DTB
Medtronic Vascular
Cardiovascular · 20d
Cleared Jan 08, 1985
LIGHT REFLECTION RHEOGRAPHY
K833561 · JOM
Instru-Med, Inc.
Cardiovascular · 454d
Cleared Jan 08, 1985
HEPARIN COATED ARTERIAL BLOOD FILTERS
K842813 · DTM
American Bentley
Cardiovascular · 174d