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
7033–7056 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 23, 2006
LOOP RECORDER VITAPHONE, 3100 SERIES
K053378 · DXH
Tms Telemedizinische Systeme GmbH
Cardiovascular · 80d
Cleared Feb 22, 2006
INFINITY GAMMA / GAMMAXL, INFINITY VISTA
K053484 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 69d
Cleared Feb 17, 2006
THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE...
K060221 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 18d
Cleared Feb 17, 2006
ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES
K060091 · JOW
Alliance Medical Corp.
Cardiovascular · 36d
Cleared Feb 17, 2006
DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)
K052828 · DRS
Hospira, Inc.
Cardiovascular · 135d
Cleared Feb 17, 2006
KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K052676 · DXN
Kodon(Tianjin)Electronic&Electrical...
Cardiovascular · 143d
Cleared Feb 17, 2006
SPIDERX EMBOLIC PROTECTION DEVICE
K052659 · NTE
Ev3, Inc.
Cardiovascular · 143d
Cleared Feb 17, 2006
TITAN STEERABLE (PTCA) GUIDEWIRE
K052347 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 172d
Cleared Feb 17, 2006
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
K052057 · MKJ
Medtronic Emergency Response Systems,...
Cardiovascular · 203d
Cleared Feb 15, 2006
HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS
K053575 · JOW
Hygia Health Services, Inc.
Cardiovascular · 55d
Cleared Feb 13, 2006
MARCH HEALTHCARE HEALTH MONITORING KIT
K060194 · DXN
March Healthcare Corporation
Cardiovascular · 19d
Cleared Feb 13, 2006
REPROCESSED COMPRESSION SLEEVES
K053316 · JOW
Alliance Medical Corp.
Cardiovascular · 76d
Cleared Feb 13, 2006
EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.
K052965 · DRB
Guidant Corporation
Cardiovascular · 115d
Cleared Feb 09, 2006
PBS MODEL 701A COMPRESSION THERAPY DEVICE
K060220 · JOW
Mego Afek
Cardiovascular · 10d
Cleared Feb 08, 2006
INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
K053618 · MUD
Hutchinson Technology, Inc.
Cardiovascular · 42d
Cleared Feb 07, 2006
VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS
K060142 · DSY
Vascutek, Ltd.
Cardiovascular · 19d
Cleared Feb 07, 2006
LYSUS INFUSION SYSTEM
K060084 · QEY
Ekos Corp.
Cardiovascular · 27d
Cleared Feb 03, 2006
ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II
K053006 · DXQ
Rossmax Internationl , Ltd.
Cardiovascular · 100d
Cleared Feb 03, 2006
HOCA EZ-CARE BP108, TENDER-CARE BP109
K052671 · DXN
Hoca Medical Microsystem, Inc.
Cardiovascular · 129d
Cleared Feb 03, 2006
DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN,...
K051217 · MHX
Ge Healthcare
Cardiovascular · 267d
Cleared Feb 02, 2006
LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM
K052446 · DRT
Hoana Medical, Inc.
Cardiovascular · 148d
Cleared Feb 01, 2006
LUCAS
K053403 · DRM
Jolife AB
Cardiovascular · 57d
Cleared Feb 01, 2006
TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS)
K052608 · DRG
Bl Healthcare, Inc.
Cardiovascular · 132d
Cleared Jan 31, 2006
FIBERED IDC OCCLUSION SYSTEM
K060078 · KRD
Boston Scientific Corporation
Cardiovascular · 21d