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
7801–7824 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 25, 2003
MONITOR, MODEL HSM-00200
K031153 · DPW
Arrow Intl., Inc.
Cardiovascular · 228d
Cleared Nov 25, 2003
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL,...
K031340 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 211d
Cleared Nov 25, 2003
JSA REPROCESSED COMPRESSION SLEEVE DEVICES
K031722 · JOW
Jack Speer and Assoc., Inc.
Cardiovascular · 175d
Cleared Nov 24, 2003
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
K033492 · MHX
Ge Medical Systems Information...
Cardiovascular · 20d
Cleared Nov 21, 2003
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K031842 · PDU
Intra Luminal Therapeutics, Inc.
Cardiovascular · 158d
Cleared Nov 21, 2003
BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER
K033441 · DQY
Boston Scientific Corp
Cardiovascular · 23d
Cleared Nov 21, 2003
PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE...
K033444 · MHX
Philips Medical Systems
Cardiovascular · 23d
Cleared Nov 20, 2003
TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE
K032613 · LDF
Peter M. Rothenberg, M.D.
Cardiovascular · 87d
Cleared Nov 19, 2003
COOK CODA BALLOON CATHETER
K032869 · DQY
Cook, Inc.
Cardiovascular · 65d
Cleared Nov 19, 2003
TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050
K033188 · MMX
Idev Technologies, Inc.
Cardiovascular · 49d
Cleared Nov 19, 2003
SCOUT PRO
K033320 · DQY
Biotronik, Inc.
Cardiovascular · 35d
Cleared Nov 19, 2003
SPEEDLYSER INFUSION CATHETER KIT
K033443 · QEY
AngioDynamics, Inc.
Cardiovascular · 21d
Cleared Nov 18, 2003
ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
K032784 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 71d
Cleared Nov 14, 2003
AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE
K033468 · DTM
Medtronic Perfusion Systems
Cardiovascular · 11d
Cleared Nov 13, 2003
ZOLL AUTOCLAVABLE INTERNAL HANDLES
K032691 · LDD
Zoll Medical Corp
Cardiovascular · 72d
Cleared Nov 13, 2003
DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES
K033144 · MKJ
Defibtech, LLC
Cardiovascular · 44d
Cleared Nov 12, 2003
RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES
K031559 · JOW
Renu Medical, Inc.
Cardiovascular · 177d
Cleared Nov 12, 2003
ENDO PAT 2000
K032519 · DQK
Itamar Medical
Cardiovascular · 89d
Cleared Nov 12, 2003
MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
K032852 · DRM
Revivant Corp.
Cardiovascular · 61d
Cleared Nov 12, 2003
KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY...
K033021 · DWJ
Kimberly-Clark Corp.
Cardiovascular · 47d
Cleared Nov 12, 2003
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
K033304 · MHX
Ge Medical Systems Information...
Cardiovascular · 29d
Cleared Nov 10, 2003
BLOOD PRESSURE MONITOR, MODEL M100
K032308 · DXN
Meditek Technology, Inc.
Cardiovascular · 108d
Cleared Nov 10, 2003
STAR (LUNAR SERIES) MONITORING SYSTEM
K032867 · MWI
Larsen & Toubro Limited
Cardiovascular · 56d
Cleared Nov 10, 2003
PLANET MONITORING SYSTEM
K032871 · MWI
Larsen & Toubro Limited
Cardiovascular · 56d