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
7273–7296 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 27, 2005
BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80...
K050006 · DRQ
C.R. Bard, Inc.
Cardiovascular · 144d
Cleared May 27, 2005
VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY
K050146 · DXC
Vascular Solutions, Inc.
Cardiovascular · 123d
Cleared May 27, 2005
PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)
K051067 · MJN
LeMaitre Vascular, Inc.
Cardiovascular · 31d
Cleared May 26, 2005
CANALIZER HYDROPHILIC GUIDE WIRE
K050873 · DQX
Medical Device Technologies, Inc.
Cardiovascular · 50d
Cleared May 26, 2005
ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
K051060 · DQY
AngioDynamics, Inc.
Cardiovascular · 30d
Cleared May 25, 2005
ELECTRODE
K050248 · DRX
Electramold
Cardiovascular · 111d
Cleared May 25, 2005
ULTRA-SOFT SV BALLOON DILATATION CATHETER
K050389 · DQY
Boston Scientific Corp
Cardiovascular · 99d
Cleared May 20, 2005
THE HERMES SYSTEM
K050929 · DRG
Palaistra Systems, Inc.
Cardiovascular · 36d
Cleared May 20, 2005
D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O...
K051232 · DTM
Dideco S.R.L.
Cardiovascular · 7d
Cleared May 19, 2005
ENPATH DEFLECTABLE CATHETER
K043489 · DQY
Enpath Medical Incorporated
Cardiovascular · 153d
Cleared May 19, 2005
SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM
K050731 · MWJ
Ge Medical Systems Information...
Cardiovascular · 59d
Cleared May 19, 2005
ADAPTER CABLE
K050884 · DTA
Remington Medical, Inc.
Cardiovascular · 42d
Cleared May 19, 2005
CARDIOSCOPE SONOPLUS 3000
K051126 · DPS
Pulsonic Ag, Medical Technology
Cardiovascular · 16d
Cleared May 18, 2005
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
K050168 · DQO
Vascular Solutions, Inc.
Cardiovascular · 112d
Cleared May 17, 2005
APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582
K051096 · DYB
St. Jude Medical, Daig Division, Inc.
Cardiovascular · 18d
Cleared May 13, 2005
MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
K050093 · DQK
Ge Medical Systems Information...
Cardiovascular · 119d
Cleared May 13, 2005
VITALWARE VMS
K050128 · DRG
Televital, Inc.
Cardiovascular · 114d
Cleared May 13, 2005
KERBEROS PROXIMAL SOLUTIONS RISPIRATION SYSTEM
K050130 · QEZ
Kerberos Proximal Solutions, Inc.
Cardiovascular · 112d
Cleared May 13, 2005
BLOOD PRESSURE MONITOR WITH SPECTRUM/P2, X2, A2, AND K7
K050680 · DXN
OSTAR MEDITECH CORP.
Cardiovascular · 58d
Cleared May 13, 2005
ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES
K051076 · MKJ
ZOLL Medical Corporation
Cardiovascular · 16d
Cleared May 09, 2005
TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060
K050926 · MMX
Idev Technologies, Inc.
Cardiovascular · 26d
Cleared May 06, 2005
CONCENTRIC EMBOLIC PEARLS
K050470 · KRD
Concentric Medical, Inc.
Cardiovascular · 72d
Cleared May 06, 2005
MERIT PRELUDE SHEATH INTRODUCER
K050962 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 18d
Cleared May 05, 2005
GUNTHER TULIP VENA CAVA FILTER SET
K043509 · DTK
Cook, Inc.
Cardiovascular · 136d