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
17905–17928 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 14, 1977
DIGITAL HEART RATE METER
K770239 · DRT
Burdick Corp.
Cardiovascular · 7d
Cleared Feb 14, 1977
ELGILOY STYLET
K770243 · DRR
Cardiac Pacemakers, Inc.
Cardiovascular · 7d
Cleared Feb 14, 1977
D.C. AMPLIFIER MODULE
K770247 · DRQ
Mennen Greatbatch Electonics
Cardiovascular · 7d
Cleared Feb 07, 1977
LEAD MODIFICATION
K770135 · DXY
Elema-Schonander, Inc.
Cardiovascular · 14d
Cleared Feb 07, 1977
PERM. IMPLANT. ENDOCARDIAL PAC. LEAD
K770195 · DTB
Daig Corp.
Cardiovascular · 7d
Cleared Feb 07, 1977
UNIPOLAR, ASYNCHRONOUS PULSE GENERATOR
K770197 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 7d
Cleared Feb 07, 1977
BIPOLAR ASYNCHRONOUS PULSE GENERATOR
K770198 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 7d
Cleared Feb 07, 1977
LEAD EXTENDER MODEL 6516
K770199 · DTD
Cardiac Pacemakers, Inc.
Cardiovascular · 7d
Cleared Feb 01, 1977
ANASTOMASIS OCCLUDER
K761328 · DWS
Medical Engineering Corp.
Cardiovascular · 36d
Cleared Feb 01, 1977
LIFEPATCH TM ECG ELECTRODE
K770083 · DRX
Physio-Control Corp.
Cardiovascular · 18d
Cleared Feb 01, 1977
ARTERIAL DIAGNOSTIC UNIT (ADU)
K770115 · DPW
Medical Electronic Devices, Inc.
Cardiovascular · 13d
Cleared Jan 31, 1977
SIMULATOR, 10 LEAD ECG
K761023 · DPS
Birtcher Corp.
Cardiovascular · 81d
Cleared Jan 28, 1977
TR-3 TRANSMITTER
K760857 · DXH
Burdick Corp.
Cardiovascular · 105d
Cleared Jan 25, 1977
PRIMUS INTER PARESECHOCARDIOGRAPHY SYS.
K770073 · DXK
Rohe Scientific Corp.
Cardiovascular · 12d
Cleared Jan 21, 1977
AUTOMATIC ELECTRONIC SPHYGMOMANOMETER
K760738 · DXN
Medical Monitors, Inc.
Cardiovascular · 115d
Cleared Jan 14, 1977
PACING KIT, ELECATH TRANSTHORACIC
K770016 · DTR
Electro-Catheter Corp.
Cardiovascular · 10d
Cleared Jan 14, 1977
PACING KIT, TRANSMYOCARDIAL
K770017 · DTR
Electro-Catheter Corp.
Cardiovascular · 10d
Cleared Jan 14, 1977
PACING KIT, SEMI-FLOATING
K770018 · DTR
Electro-Catheter Corp.
Cardiovascular · 10d
Cleared Jan 14, 1977
CARDIOTOMY RESERVOIR
K770036 · DTN
Shiley, Inc.
Cardiovascular · 4d
Cleared Jan 14, 1977
ELECTROCARDIOGRAPH MODEL 344
K770037 · DPS
Birtcher Corp.
Cardiovascular · 4d
Cleared Jan 14, 1977
MONITOR, HEARTWATCH HEART RATE
K770038 · DRT
Respironics, Inc.
Cardiovascular · 4d
Cleared Jan 12, 1977
FLUSHFLO-MODEL CC1-6
K761273 · KRA
Bentley Laboratories, Inc.
Cardiovascular · 23d
Cleared Jan 12, 1977
ADAPTER, LEAD, GENERAL ELECTRIC
K770042 · DTD
Cardiac Pacemakers, Inc.
Cardiovascular · 2d
Cleared Jan 06, 1977
3038 OPTION B-COMPUT. TRANS. TERMINAL
K761318 · DXH
Cambridge Instruments, Inc.
Cardiovascular · 10d