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
8785–8808 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 11, 2001
H-SCRIBE
K004017 · MLO
Mortara Instrument, Inc.
Cardiovascular · 166d
Cleared Jun 11, 2001
HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT...
K010634 · MKJ
Agilent Technologies, Inc.
Cardiovascular · 101d
Cleared Jun 11, 2001
BPFONE, MODEL UA 767IT
K010751 · DXN
Medical Monitors Pty Limited
Cardiovascular · 90d
Cleared Jun 08, 2001
ORIGEN DUAL LUMEN CATHETER
K003288 · DQO
Origen Biomedical, Inc.
Cardiovascular · 231d
Cleared Jun 08, 2001
WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM
K010186 · DXN
Welch Allyn, Inc.
Cardiovascular · 137d
Cleared Jun 08, 2001
REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)
K010791 · DXH
Adsis , Ltd.
Cardiovascular · 85d
Cleared Jun 08, 2001
M2376A DEVICELINK SYSTEM, MODEL M2376A
K011578 · MWI
Agilent Technologies, Inc.
Cardiovascular · 17d
Cleared Jun 06, 2001
PARODI CATHETER FOR ANGIOGRAPHY (PARCA)
K001917 · MJN
Arteria Medical Science, Inc.
Cardiovascular · 348d
Cleared Jun 06, 2001
BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755
K003570 · MCW
Bacchus Vascular, Inc.
Cardiovascular · 198d
Cleared Jun 06, 2001
CPR EZY MASK AND PAD
K003937 · LIX
Medteq Innovations Pty, Ltd.
Cardiovascular · 168d
Cleared Jun 06, 2001
TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A
K010083 · DTK
Cordis Corp.
Cardiovascular · 146d
Cleared Jun 06, 2001
AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569
K010471 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 106d
Cleared Jun 06, 2001
SPARROWHAWK DISPOSABLE
K010473 · DWZ
Atc Technologies, Inc.
Cardiovascular · 106d
Cleared Jun 01, 2001
PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
K003992 · NFA
Percu Surge, Inc.
Cardiovascular · 157d
Cleared May 31, 2001
CADHEALTH SYSTEM, MODEL CHP-001
K002514 · DRG
Caduceus Health Care , Ltd.
Cardiovascular · 289d
Cleared May 31, 2001
INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX
K002847 · DYB
Maxxim Medical
Cardiovascular · 260d
Cleared May 31, 2001
VASOTRAC APM205A
K011152 · DXN
Medwave, Inc.
Cardiovascular · 45d
Cleared May 25, 2001
RADIUS COUGAR WIRE
K011287 · DQX
Radius Medical Technologies, Inc.
Cardiovascular · 28d
Cleared May 23, 2001
BIOCONNECT PATIENT MONITORING CABLES AND LEADWIRES, CAT# 1000 THRU CAT# 40000
K010809 · DSA
Rf Industries, Ltd.
Cardiovascular · 68d
Cleared May 23, 2001
BCI ADVISOR VITAL SIGNS MONITOR (9200)
K011177 · DPS
Bci, Inc.
Cardiovascular · 36d
Cleared May 23, 2001
CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM
K011324 · DQK
Cambridge Heart, Inc.
Cardiovascular · 22d
Cleared May 22, 2001
BIOSPHERE MEDICAL INFUSION CATHETER
K003105 · DQO
Biosphere Medical
Cardiovascular · 230d
Cleared May 22, 2001
CONCENTRIC RETRIEVER, MODEL 90030
K003410 · DQY
Concentric Medical, Inc.
Cardiovascular · 201d
Cleared May 22, 2001
OSCOR PERMANENT PACING LEAD RZ MODEL SERIES
K003918 · DTB
Oscor, Inc.
Cardiovascular · 154d