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
17833–17856 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 14, 1977
TS-100 TEST SYSTEM
K771014 · KRC
Delta Medical Industries
Cardiovascular · 8d
Cleared Jun 14, 1977
AUTO-CLIP
K771021 · DSS
Axiom Medical, Inc.
Cardiovascular · 8d
Cleared Jun 08, 1977
AQUAMATIC K-77
K770839 · DWJ
Gorman Rupp Industries
Cardiovascular · 30d
Cleared Jun 03, 1977
PORTASCOPE II
K770832 · DPS
Mennen Greatbatch Electonics
Cardiovascular · 28d
Cleared Jun 02, 1977
CARDIAC ACQUISITION SYSTEM, ICR 2001
K770705 · DQK
Instruments For Cardiac Research
Cardiovascular · 45d
Cleared Jun 02, 1977
SPHYGMOMANOMETER, ELECTRONIC
K770921 · DXN
Bristoline, Inc.
Cardiovascular · 13d
Cleared Jun 02, 1977
COMPUTER ECG TELE. TRANSMISSION TERMINAL
K770949 · DXH
The Okun Co.
Cardiovascular · 8d
Cleared May 23, 1977
ELHCTROCARDIOGRAPHIC CONNECTING WIRES
K770884 · DSA
Tronomed, Inc.
Cardiovascular · 7d
Cleared May 18, 1977
RECORDING UNIT, MODEL 1445
K770829
Scole Engineering Co.
Cardiovascular · 13d
Cleared May 09, 1977
ECHOCARDIOGRAPHY SYS., MODEL 3830
K770755 · DXK
Honeywell, Inc.
Cardiovascular · 14d
Cleared May 09, 1977
ECHOCARDIOGRAPHY SYS., MODEL 3860
K770756 · DXK
Honeywell, Inc.
Cardiovascular · 14d
Cleared May 09, 1977
PULSE/PHONOCARDIOGRAPHY CHANNEL, 144
K770757 · DQC
Honeywell, Inc.
Cardiovascular · 14d
Cleared May 06, 1977
MONITOR, PORTABLE, PATIENT, G.E.
K770760 · DPS
General Electric Co.
Cardiovascular · 11d
Cleared May 06, 1977
PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT
K770821 · DSP
Avco Medical Products
Cardiovascular · 2d
Cleared Apr 27, 1977
PROBE, TEMPERATURE, SYSTEM, SARNS
K770709 · DRF
3M Health Care, Sarns
Cardiovascular · 9d
Cleared Apr 27, 1977
CATHETER, ARTERIAL EMBOLECTOMY
K770714 · DXE
Mallinckrodt Critical Care
Cardiovascular · 9d
Cleared Apr 26, 1977
BLOOD RESERVOIR
K770546 · DTN
Delta Medical Industries
Cardiovascular · 36d
Cleared Apr 26, 1977
CATHETER,PERCUTANEOUS INTRODUC. & SHEATH
K770561 · DYB
Usci, Div. C.R. Bard, Inc.
Cardiovascular · 34d
Cleared Apr 26, 1977
GENERATOR, PULSE, CARDIAC 20U
K770656 · DXY
Edwards Pacemaker Systems
Cardiovascular · 19d
Cleared Apr 26, 1977
GENERATOR, PULSE, CARDIAC 2LU
K770657 · DXY
Edwards Pacemaker Systems
Cardiovascular · 19d
Cleared Apr 26, 1977
GENERATOR, PULSE, IMPLANTABLE
K770661 · DXY
Med Telectronics , Ltd.
Cardiovascular · 19d
Cleared Apr 26, 1977
COMPUTER, CARDIAC OUTPUT, MODEL KM275
K770675 · DXG
Lexington Instruments
Cardiovascular · 15d
Cleared Apr 26, 1977
VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR
K770681 · KRI
Scimed Life Systems, Inc.
Cardiovascular · 15d
Cleared Apr 26, 1977
GENERATOR, PULSE, UNIPOLAR, MODEL #504
K770716 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 8d