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
16561–16584 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 13, 1981
KENL-ECG
K811950 · DPS
Suzuken Co., Ltd.
Cardiovascular · 37d
Cleared Aug 13, 1981
CORDIS DUCOR PTR SYSTEM
K811971 · DQY
Cordis Corp.
Cardiovascular · 34d
Cleared Aug 13, 1981
SPHGOMOMANOMETER
K812059 · DXN
Med-Tek Corp.
Cardiovascular · 23d
Cleared Aug 13, 1981
COBE HEAT EXCHANGER RESERVOIR MODULE
K812093 · DTR
Cobe Laboratories, Inc.
Cardiovascular · 20d
Cleared Aug 12, 1981
USCI DOPPLER CATHETER SYSTEM
K810414 · JOP
C.R. Bard, Inc.
Cardiovascular · 175d
Cleared Aug 12, 1981
DOPPLER ULTRASOUND BLOOD FLOWMETER
K811246 · DPW
Irex Corp.
Cardiovascular · 99d
Cleared Aug 12, 1981
TEFLON PLEDGET SUTURE BUTTRESS
K811872 · DXZ
Ethicon, Inc.
Cardiovascular · 42d
Cleared Aug 07, 1981
TYPE FH ENDOCARDIAL LEAD
K810494 · DTB
Biotronik Sales, Inc.
Cardiovascular · 164d
Cleared Aug 07, 1981
ADAPTAID LEAD ADAPTER #365-25
K811938 · DTD
Intermedics, Inc.
Cardiovascular · 32d
Cleared Aug 03, 1981
MODEL 84 TRANSPORT SYSTEM
K811372 · DSP
Datascope Corp.
Cardiovascular · 80d
Cleared Aug 03, 1981
ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR
K811758 · DXH
Powers Medical Systmes
Cardiovascular · 42d
Cleared Aug 03, 1981
MODEL D BIPOLAR ENDOCARDIAL LEAD
K811876 · DTB
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Aug 03, 1981
MODEL C UNIPOLAR ENDOCARDIAL LEAD
K811877 · DTB
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Aug 03, 1981
MODEL B BIPOLAR ENDOCARDIAL LEAD
K811878 · DTB
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Aug 03, 1981
MODEL A UNIPOLAR ENDOCARDIAL LEAD
K811879 · DTB
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Jul 28, 1981
SINGLE CHANNEL NON-FADE OSCILLOSCOPE
K811911 · DXJ
Quinton, Inc.
Cardiovascular · 27d
Cleared Jul 28, 1981
ELECTRONIC BLOOD PRESSURE TRANSDUCER MAN
K811980 · DRS
H.R. Biomedical, Ltd.
Cardiovascular · 15d
Cleared Jul 28, 1981
CORDIOTOMY RESERVOIR
K812008 · DTN
Bentley Laboratories, Inc.
Cardiovascular · 11d
Cleared Jul 28, 1981
CARDIOTOMY RESERVOIR W/FILTER#BCR-3500
K812009 · DTN
Bentley Laboratories, Inc.
Cardiovascular · 11d
Cleared Jul 27, 1981
COMMAND P5(UNIPOLAR PULSE GENERATOR)
K811401
Cardiac Pacemakers, Inc.
Cardiovascular · 69d
Cleared Jul 27, 1981
COMMAND P5(BIPOLAR PULSE GENERATOR)
K811402 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 70d
Cleared Jul 27, 1981
OXY-QUIK MARK IV OXYGEN INHALATOR
K811987 · DRM
Oxequip Health Ind.
Cardiovascular · 14d
Cleared Jul 21, 1981
OXYGEN CONTROLLER MODEL 145
K812038
Medix Medical Electronics (U.S.A.), Inc.
Cardiovascular
Cleared Jul 20, 1981
ELA MEDICAL UNILITH 7540 PULSE GENERATOR
K810887 · DXY
Ela Medical, Inc.
Cardiovascular · 110d