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
14449–14472 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 08, 1986
PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337
K860805 · DQO
Gould, Inc.
Cardiovascular · 65d
Cleared May 08, 1986
EM STRESS ELECTRODE
K860827 · DRX
Electromed Intl., Ltd.
Cardiovascular · 64d
Cleared May 07, 1986
DJ UNIPOLAR
K853566 · DTB
Biotronik Sales, Inc.
Cardiovascular · 254d
Cleared May 07, 1986
DJP UNIPOLAR
K853567 · DTB
Biotronik Sales, Inc.
Cardiovascular · 254d
Cleared May 07, 1986
DISPOSABLE PRESSURE TRANSDUCER SYSTEM STERILE
K853996 · DRS
Transamerica Delaval, Inc.
Cardiovascular · 219d
Cleared May 07, 1986
MEADOX MEDICALS INC. GRAFT SIZER
K854431 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 183d
Cleared May 07, 1986
TDK ECG ELECTRODE MEL-08-09 & -11
K854596 · DRS
Tdk Corp.
Cardiovascular · 170d
Cleared May 07, 1986
PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A
K854840 · DPS
Ivy Biomedical Systems, Inc.
Cardiovascular · 154d
Cleared May 07, 1986
KONTRON INTRA-AORTIC BALLOON PUMP MODEL KAAT
K860427 · DSP
Kontron Instruments, Inc.
Cardiovascular · 92d
Cleared May 05, 1986
STETHOSCOPE ELECTRONIC STETHOSCOPE SPHYGMOMANOMETE
K854356 · DQD
Fontaine Industries, Inc.
Cardiovascular · 188d
Cleared May 05, 1986
MODEL 500A VASCULAR SPECTRUM ANALYZER W/CW DOPPLER
K860435 · DPT
Multigon Industries, Inc.
Cardiovascular · 90d
Cleared May 05, 1986
CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST
K861082 · DYB
Cordis Corp.
Cardiovascular · 45d
Cleared May 05, 1986
PHARMASEAL DUAL LUMEN CATHETER
K861165 · DQY
American Pharmaseal Div. Ahsc
Cardiovascular · 38d
Cleared May 05, 1986
SYNCARE TEMPORARY CARDIAC PACING WIRE
K861409 · LDF
Gyneco, Inc.
Cardiovascular · 20d
Cleared May 02, 1986
595 ARRHYTHMIA MONITORING SYSTEM
K852250 · DSI
Burdick Corp.
Cardiovascular · 344d
Cleared May 02, 1986
HEART CATHETERIZATION TRAY
K860161 · DRE
Medical Design Concepts, Inc.
Cardiovascular · 106d
Cleared May 02, 1986
ANGIOMAT 6000
K860204 · DXT
Mallinckrodt Group, Inc.
Cardiovascular · 100d
Cleared May 02, 1986
NOVA BALLOON THERMODILUTION PRESSURE TRANS CATH
K860526 · DXO
Nova Medical Specialties
Cardiovascular · 80d
Cleared May 02, 1986
SCM-400 HOLTER SYSTEM
K860950 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 51d
Cleared May 02, 1986
PROGRAMALITH III PULSE GENERATOR
K861140 · DXY
Pacesetter Systems
Cardiovascular · 37d
Cleared May 02, 1986
BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER
K861240 · DSI
Mountain View Medical
Cardiovascular · 30d
Cleared May 01, 1986
DCI MODEL EP-2 CLINICAL STIMULATOR
K854196 · DRO
Digital Cardiovascular Instruments, Inc.
Cardiovascular · 198d
Cleared Apr 30, 1986
DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST
K860470 · DSI
Del Mar Avionics
Cardiovascular · 83d
Cleared Apr 30, 1986
DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER
K860471 · DSI
Del Mar Avionics
Cardiovascular · 83d