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
8353–8376 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 26, 2002
JUMP START, MODEL 970300
K021168 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 76d
Cleared Jun 24, 2002
CARDEON AEGIS CATHETER
K013593 · DWF
Cardeon Corp.
Cardiovascular · 237d
Cleared Jun 24, 2002
M2376 DEVICELINK SYSTEM
K021912 · MWI
Philips Medical Systems, Inc.
Cardiovascular · 13d
Cleared Jun 20, 2002
EQUALIZER BALLOON CATHETER
K021721 · DQY
Boston Scientific Corp
Cardiovascular · 27d
Cleared Jun 19, 2002
SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR
K013896 · MKJ
Defibtech, LLC
Cardiovascular · 208d
Cleared Jun 18, 2002
MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM
K021066 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 77d
Cleared Jun 17, 2002
BLOOD-PRESSURE METER
K021252 · DXN
Idt Technology Limited
Cardiovascular · 59d
Cleared Jun 14, 2002
AIRCAST, MODEL #3011
K013297 · JOW
Millenium Reprocessing Services, Inc.
Cardiovascular · 254d
Cleared Jun 14, 2002
EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL...
K020857 · DRN
Vasomedical, Inc.
Cardiovascular · 88d
Cleared Jun 14, 2002
OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL,...
K020896 · DTE
Osypka Medical, Inc.
Cardiovascular · 87d
Cleared Jun 14, 2002
RADIUS SNARE
K021441 · MMX
Radius Medical Technologies, Inc.
Cardiovascular · 39d
Cleared Jun 13, 2002
SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS
K013022 · DSY
Sulzer Carbomedics, Inc.
Cardiovascular · 279d
Cleared Jun 13, 2002
MODIFICATION TO ENVOY AND VISTA BRITE TIP
K021593 · DQY
Cordis Corp.
Cardiovascular · 29d
Cleared Jun 12, 2002
BD INTROSYTE PRECISION INTRODUCER
K020834 · DYB
Becton Dickinson Infusion Therapy...
Cardiovascular · 90d
Cleared Jun 06, 2002
VALVED PEELABLE INTRODUCER
K021004 · DYB
Medamicus, Inc.
Cardiovascular · 70d
Cleared Jun 06, 2002
MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE
K021010 · OCL
Endocare, Inc.
Cardiovascular · 69d
Cleared Jun 06, 2002
ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A...
K021462 · DSP
Arrow Intl., Inc.
Cardiovascular · 30d
Cleared Jun 04, 2002
PHYSIOLOG, SERIES 95000
K013032 · DQK
Camtronics, Ltd.
Cardiovascular · 267d
Cleared Jun 03, 2002
SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117
K020821 · DQX
Biotronik, Inc.
Cardiovascular · 82d
Cleared Jun 03, 2002
CHARE CARIOVASCULAR PATCH
K021129 · DXZ
Chase Medical, Inc.
Cardiovascular · 56d
Cleared May 31, 2002
EN-SNARE ENDOVASCULAR SNARE AND CATHETER
K021606 · MMX
Medical Device Technologies, Inc.
Cardiovascular · 15d
Cleared May 30, 2002
ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A
K021587 · DQY
Medtronic Vascular
Cardiovascular · 15d
Cleared May 30, 2002
ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218
K021589 · DQY
Medtronic Vascular
Cardiovascular · 15d
Cleared May 29, 2002
MICRO-INDUCTION 1000 SYSTEM
K013615 · DPS
Harbinger Medical, Inc.
Cardiovascular · 205d