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
5977–6000 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 09, 2009
ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING
K081081 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 327d
Cleared Mar 06, 2009
SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM
K082528 · DQD
Noble Anesthesia-Air, Inc.
Cardiovascular · 185d
Cleared Mar 03, 2009
MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE
K090274 · DQX
Micrus Endovascular Corporation
Cardiovascular · 27d
Cleared Mar 02, 2009
REEKROSS FAMILY OR OTW PTA CATHETERS
K083596 · DQY
ClearStream Technologies , Ltd.
Cardiovascular · 87d
Cleared Feb 27, 2009
CONCERTO DETACHABLE COIL SYSTEM
K090046 · KRD
Micro Therapeutics, Inc.
Cardiovascular · 51d
Cleared Feb 27, 2009
SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS:...
K083395 · DXN
Andon Health Co, Ltd.
Cardiovascular · 102d
Cleared Feb 27, 2009
PROTRON TECHNOLOGIES, LLC STETHOTRON
K082771 · DQD
Protron Technologies, LLC
Cardiovascular · 158d
Cleared Feb 25, 2009
TAD AND TAD II TAPERED GUIDE WIRES
K083732 · DQX
Abbott Vascular
Cardiovascular · 71d
Cleared Feb 25, 2009
ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC
K083683 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 75d
Cleared Feb 25, 2009
INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60,...
K082583 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 170d
Cleared Feb 23, 2009
.035 LOC GUIDE WIRE EXTENSION
K083713 · DQX
Abbott Vascular
Cardiovascular · 70d
Cleared Feb 23, 2009
E.S TECK ( ELECTRO SENSOR TECK)
K083229 · MWI
Ld Technology, LLC
Cardiovascular · 112d
Cleared Feb 20, 2009
STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012
K083727 · DQX
Bridgepoint Medical
Cardiovascular · 67d
Cleared Feb 19, 2009
MAC 800 RESTING ECG ANALYSIS SYSTEM
K090212 · DPS
Ge Medical Syst. Information...
Cardiovascular · 22d
Cleared Feb 19, 2009
CARDITTE MICROTEL
K082124 · DPS
Et Medical Devices Spa
Cardiovascular · 206d
Cleared Feb 18, 2009
ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS
K083735 · JOM
Medtechs, LLC
Cardiovascular · 64d
Cleared Feb 18, 2009
QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE...
K082117 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 205d
Cleared Feb 17, 2009
NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123...
K090202 · OCL
Ncontact Surgical, Inc.
Cardiovascular · 21d
Cleared Feb 17, 2009
MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59
K083855 · DYB
Acumen Medical, Inc.
Cardiovascular · 55d
Cleared Feb 17, 2009
MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE
K083639 · DQK
Ge Medical Systems Information...
Cardiovascular · 70d
Cleared Feb 13, 2009
CARDIAC TRIGGER, MODEL: CTM300
K083854 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 51d
Cleared Feb 13, 2009
ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33
K083309 · DQD
Zargis Medical Corp.
Cardiovascular · 95d
Cleared Feb 13, 2009
CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE
K082930 · DXC
Cardiva Medical, Inc.
Cardiovascular · 135d
Cleared Feb 13, 2009
TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
K082321 · KFM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 184d