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
5929–5952 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 22, 2009
YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-700, BP-700T, BP700U,...
K090058 · DXN
Ya Horng Electronic Co., Ltd.
Cardiovascular · 104d
Cleared Apr 21, 2009
MECC SET WITH BIOLINE COATING
K083794 · KFM
Maquet Cardiopulmonary, AG
Cardiovascular · 120d
Cleared Apr 20, 2009
PARADIS VASO SHIELD
K090022 · OMR
Spinemedica, LLC
Cardiovascular · 105d
Cleared Apr 17, 2009
TERUMO PALL AL6X ARTERIAL FILTER
K083834 · DTM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 115d
Cleared Apr 16, 2009
HYPERGLIDE OCCLUSION BALLOON SYSTEM
K090728 · MJN
Ev3, Inc.
Cardiovascular · 28d
Cleared Apr 16, 2009
IMPELLA 5.0 CATHETER FAMILY
K083111 · KFM
Abiomed, Inc.
Cardiovascular · 177d
Cleared Apr 15, 2009
BIOCARDIA MORPH SHEATH GUIDE
K090999 · DYB
Biocardia, Inc.
Cardiovascular · 7d
Cleared Apr 15, 2009
RTX 3371
K090886 · DRG
Tunstall Healthcare
Cardiovascular · 15d
Cleared Apr 15, 2009
MODIFICATION TO DASH 2500 PATIENT MONITOR
K090702 · MHX
Ge Medical Systems Information...
Cardiovascular · 29d
Cleared Apr 15, 2009
CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100
K083623 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 128d
Cleared Apr 13, 2009
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
K083534 · DRT
Hoana Medical, Inc.
Cardiovascular · 136d
Cleared Apr 10, 2009
DETLOGIX ANNULOPLASTY RING, MODEL: 5100
K083191 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 163d
Cleared Apr 09, 2009
CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE
K090014 · DXQ
Caremate Medical Device Co., Ltd.
Cardiovascular · 97d
Cleared Apr 08, 2009
ELECTRONIC HOUSE CALL
K090801 · DRG
Express MD Solutions, LLC
Cardiovascular · 15d
Cleared Apr 08, 2009
ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA...
K090253 · QEZ
Possis Medical, Inc.
Cardiovascular · 65d
Cleared Apr 03, 2009
MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING)
K090878 · DWF
Terumo Cardiovascular Systems Corp.
Cardiovascular · 3d
Cleared Apr 03, 2009
MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM
K090249 · DPS
Harbinger Medical, Inc.
Cardiovascular · 60d
Cleared Apr 03, 2009
GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER
K090140 · DTK
William Cook Europe Aps
Cardiovascular · 72d
Cleared Apr 03, 2009
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C
K082327 · MUD
Somanetics Corp.
Cardiovascular · 232d
Cleared Apr 02, 2009
COOK MREYE EMBOLIZATION COILS
K090624 · KRD
Cook, Inc.
Cardiovascular · 24d
Cleared Apr 02, 2009
REPLICATION MEDICAL VESSEL GUARD
K082782 · OMR
Replication Medical, Inc.
Cardiovascular · 192d
Cleared Apr 01, 2009
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K090323 · NLH
Ascent Healthcare Solutions
Cardiovascular · 51d
Cleared Apr 01, 2009
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
K090163 · DRB
St Jude Medical
Cardiovascular · 69d
Cleared Apr 01, 2009
VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C
K083820 · DSH
Vasomedical, Inc.
Cardiovascular · 100d