FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
5833–5856 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 30, 2009
MEDOS HILITE RESERVOIR, MODEL: 4030
K083131 · DTN
Gish Biomedical, Inc.
Cardiovascular · 280d
Cleared Jul 29, 2009
HEART-EXERCISE
K091594 · MHX
Ge Medical Systems Information...
Cardiovascular · 57d
Cleared Jul 27, 2009
WALK400H
K091054 · MWJ
Et Medical Devices Spa
Cardiovascular · 105d
Cleared Jul 24, 2009
UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE
K091985 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 22d
Cleared Jul 24, 2009
SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6,...
K091513 · DPS
Edan Instruments, Inc.
Cardiovascular · 63d
Cleared Jul 24, 2009
DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300
K081603 · DXR
Heartforce Medical, Inc.
Cardiovascular · 413d
Cleared Jul 21, 2009
ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM
K091075 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 98d
Cleared Jul 15, 2009
PASSPORT V MONITOR, MODEL 0998-00-6100
K091834 · MHX
Datascope Corp., Patient Monitoring...
Cardiovascular · 23d
Cleared Jul 15, 2009
MODIFICATION TO MEDICOMPASS CONNECT
K091021 · DRG
Imetrikus, Inc.
Cardiovascular · 97d
Cleared Jul 15, 2009
STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55
K091008 · DWA
Sorin Group Deutschland GmbH
Cardiovascular · 97d
Cleared Jul 15, 2009
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200
K083903 · DQD
3M Company
Cardiovascular · 198d
Cleared Jul 10, 2009
M3 MONITOR
K091908 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 15d
Cleared Jul 09, 2009
AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54
K091793 · DQY
Aga Medical Corp.
Cardiovascular · 22d
Cleared Jul 09, 2009
AIRCAST VENAFLOW ELITE SYSTEM
K091700 · JOW
Djo, LLC
Cardiovascular · 29d
Cleared Jul 09, 2009
OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S
K091224 · MUD
Somanetics Corp.
Cardiovascular · 73d
Cleared Jul 08, 2009
AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM
K091882 · KRD
MicroVention, Inc.
Cardiovascular · 14d
Cleared Jul 08, 2009
ECSCOPE 200
K091397 · DPS
Dyansys, Inc.
Cardiovascular · 57d
Cleared Jul 07, 2009
STREAMER POLYMER GUIDEWIRE
K083094 · DQX
Brivant, Ltd.
Cardiovascular · 263d
Cleared Jul 02, 2009
EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST
K091596 · DRA
Evalve, Inc.
Cardiovascular · 30d
Cleared Jul 02, 2009
VORTEX CANNULA
K091304 · DWF
Vortex Medical, Inc.
Cardiovascular · 59d
Cleared Jul 02, 2009
AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05
K091007 · DTQ
Sorin Group Deutschland GmbH
Cardiovascular · 84d
Cleared Jul 02, 2009
ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE
K090554 · DQX
Boston Scientific Corp
Cardiovascular · 122d
Cleared Jul 01, 2009
SPECTRANETICS TURBO-TANDEM SYSTEM
K091299 · DQY
Spectranetics Corp.
Cardiovascular · 58d
Cleared Jul 01, 2009
CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59,...
K090613 · DQY
St. Jude Medical, Cardiac Rhythm...
Cardiovascular · 117d