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
17953–17976 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 09, 1976
ECG MONITOR (TELEPHONE ECG TRANSMITTER)
K761066 · DXH
Physio-Control Corp.
Cardiovascular · 21d
Cleared Dec 09, 1976
TC-1 CARDIAC OUTPUT COMPUTER
K761166 · DXG
Waters Assoc., Inc.
Cardiovascular · 8d
Cleared Dec 09, 1976
GRANT MODIF OF DEBAKEY ABDOM AORTA CLMP
K761169 · DXC
Pilling Co.
Cardiovascular · 8d
Cleared Dec 09, 1976
HLR QUICK-FIT HEART-LUNG RESUSCITATOR
K761194 · DRM
Mckesson Corp.
Cardiovascular · 3d
Cleared Dec 09, 1976
MODEL 3044 3-CHANNEL STRESS TEST SYSTEM
K761198 · DPS
Cambridge Instruments, Inc.
Cardiovascular · 3d
Cleared Dec 06, 1976
MULTI-PORTED FACE PLATE
K760654
Pilling Co.
Cardiovascular · 81d
Cleared Dec 06, 1976
CARDIART 108T/313
K761014 · DPS
Conway Electronic Enterprises , Ltd.
Cardiovascular · 27d
Cleared Dec 06, 1976
ELECTRONIC CONTROL UNIT
K761087 · DWJ
Gorman Rupp Industries
Cardiovascular · 14d
Cleared Dec 06, 1976
67-8006 DARLING-LINTON AORTIC TOURN.
K761161 · DWS
Codman & Shurtleff, Inc.
Cardiovascular · 7d
Cleared Dec 02, 1976
PULSAR PULSE MONITOR WATCH
K760710 · DRT
Time Computer, Inc. (Tci)
Cardiovascular · 70d
Cleared Nov 15, 1976
ELECTROCARDIOGRAPH, EK-7 (3-CHANNELS)
K760271 · DPS
Burdick Corp.
Cardiovascular · 116d
Cleared Nov 15, 1976
PRESSURE MODULE (MODEL P3)
K761017 · DRQ
Datascope Corp.
Cardiovascular · 5d
Cleared Nov 12, 1976
ELECTROCARDIOGRAPH EK-6 W/OPTIONAL CIRC.
K760268 · DPS
Burdick Corp.
Cardiovascular · 113d
Cleared Nov 12, 1976
CIRCUIT, PRINTED, SERVO-MECHANISM
K760272 · DPS
Burdick Corp.
Cardiovascular · 113d
Cleared Nov 12, 1976
PACEMAKERS, VITATRON'S
K760669 · DXY
Vitatron Medical BV
Cardiovascular · 56d
Cleared Nov 12, 1976
PACEMAKERS, VITATRONS (SERIES 2000)
K760670 · DXY
Vitatron Medical BV
Cardiovascular · 56d
Cleared Nov 12, 1976
PACEMAKERS, VITATRONS (SERIES 3000)
K760671 · DXY
Vitatron Medical BV
Cardiovascular · 56d
Cleared Nov 12, 1976
TMO OXYGENATOR RESERVOIR PUMP SET
K760823 · DTN
Travenol Laboratories, S.A.
Cardiovascular · 30d
Cleared Nov 12, 1976
TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I
K760824 · DTZ
Travenol Laboratories, S.A.
Cardiovascular · 30d
Cleared Nov 12, 1976
PALEY TRANSPARENT MANIFOLD
K760843 · DTL
Usci, Div. C.R. Bard, Inc.
Cardiovascular · 29d
Cleared Nov 12, 1976
CARDIAC OUTPUT COMPUTER (MODEL COC-100)
K760844 · DXG
B-D Electrodyne
Cardiovascular · 29d
Cleared Nov 12, 1976
THREE-CHANNEL STRESS TEST SYSTEM (M633)
K760854 · DPS
Quinton, Inc.
Cardiovascular · 28d
Cleared Nov 11, 1976
MODEL 100 CARDIAC PACEMAKER
K760757 · DXY
Pacesetter Systems
Cardiovascular · 41d
Cleared Nov 11, 1976
COOLEY ANGLED SCISSOR - 1MM PROBE POINT
K760791 · DWS
V. Mueller O.V. Baxter Healthcare Corp.
Cardiovascular · 35d