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
17713–17736 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 20, 1977
SWAN GANZ
K771043 · DYG
Clincal Instruments Corp.
Cardiovascular · 194d
Cleared Dec 20, 1977
CATHETER, CARDIOVASCULAR
K771823 · DYG
Usci, Div. C.R. Bard, Inc.
Cardiovascular · 88d
Cleared Dec 20, 1977
PULSE GENERATOR, A-V SEQ.
K772202 · DXY
Medtronic Vascular
Cardiovascular · 20d
Cleared Dec 13, 1977
OXYGENATOR, BUBBLE
K772237 · DTZ
Shiley, Inc.
Cardiovascular · 5d
Cleared Dec 08, 1977
PACER MONITOR, PULSE WIDTH
K772178 · DXH
Survival Technology, Inc.
Cardiovascular · 16d
Cleared Nov 28, 1977
HEARTBEATER
K771924 · DXG
Dunn Instruments, Inc.
Cardiovascular · 46d
Cleared Nov 28, 1977
ACUTE CARDIAC CARE SYSTEM
K772006 · DRT
Physio-Control Corp.
Cardiovascular · 38d
Cleared Nov 28, 1977
CARDIAC PACEMAKER S6001
K772009 · DXY
Vitatron Medical BV
Cardiovascular · 34d
Cleared Nov 28, 1977
CARDIAC PACEMAKER C2001
K772010 · DXY
Vitatron Medical BV
Cardiovascular · 34d
Cleared Nov 28, 1977
PACING LEAD MODEL 6991A
K772104 · DTB
Medtronic Vascular
Cardiovascular · 21d
Cleared Nov 28, 1977
CENTRAL MONITORING SYSTEM
K772152 · DXG
Burdick Corp.
Cardiovascular · 13d
Cleared Nov 22, 1977
ECG TELEMETRY SYSTEM
K772000 · DRG
Mennen Greatbatch Electonics
Cardiovascular · 32d
Cleared Nov 22, 1977
PHYSIOLOGICAL RECORDER MODEL 721A
K772052 · DSF
Datascope Corp.
Cardiovascular · 22d
Cleared Nov 22, 1977
PHYSIOLOGICAL RECORDER MODEL 740
K772054 · DSF
Datascope Corp.
Cardiovascular · 22d
Cleared Nov 22, 1977
PHYSIOLOGICAL MONITOR MODEL 871
K772056 · DRT
Datascope Corp.
Cardiovascular · 22d
Cleared Nov 22, 1977
HEARTRATE METER MODEL 650, P/N 000119
K772097 · DRT
Quinton, Inc.
Cardiovascular · 15d
Cleared Nov 22, 1977
AMPLIFIER MODULE, 78211A ECG
K772132 · DRR
Hewlett-Packard Co.
Cardiovascular · 8d
Cleared Nov 22, 1977
LIGHT-PEN SYSTEM FOR QUANTI. ANALY.
K772158 · DXG
Varian Assoc., Inc.
Cardiovascular · 6d
Cleared Nov 21, 1977
BIPOLAR LEADS, DISP.
K772103 · DTB
Medtronic Vascular
Cardiovascular · 14d
Cleared Nov 21, 1977
VEIN CLAMPS
K772137 · DXC
A&A Ent.
Cardiovascular · 7d
Cleared Nov 18, 1977
CHEST FLUID MONITOR
K772092 · DSB
Dynatech Research & Development Co.
Cardiovascular · 11d
Cleared Nov 18, 1977
IMPEDANCE RHEOGRAPH
K772093 · DQB
Dynatech Research & Development Co.
Cardiovascular · 11d
Cleared Nov 17, 1977
PUMP, BYPASS, PULSATILE, AVCO
K770937 · KFM
Avco Medical Products
Cardiovascular · 178d
Cleared Nov 17, 1977
PRESSURE TUBING
K771810 · DQO
Pharmaseal Div., Baxter Healthcare Corp.
Cardiovascular · 51d