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
4513–4536 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 13, 2012
DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
K122958 · DYB
Oscor, Inc.
Cardiovascular · 79d
Cleared Dec 13, 2012
ZOLL SUREPOWER SINGLE BAY CHARGER
K122839 · MKJ
ZOLL Medical Corporation
Cardiovascular · 87d
Cleared Dec 13, 2012
DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
K121853 · MKJ
Defibtech, LLC
Cardiovascular · 171d
Cleared Dec 13, 2012
CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)
K121398 · DQX
Guidepath Medical, Inc.
Cardiovascular · 218d
Cleared Dec 11, 2012
GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM*...
K122980 · DYB
Terumo Medical Corporation
Cardiovascular · 76d
Cleared Dec 11, 2012
CARDIOSCOPE
K121266 · DXN
Pulsecor Limited
Cardiovascular · 229d
Cleared Dec 07, 2012
OCELOT CATHETER
K123462 · PDU
Avinger, Inc.
Cardiovascular · 28d
Cleared Dec 07, 2012
TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
K123446 · DXN
United States Gtm Medical Devices, Inc.
Cardiovascular · 29d
Cleared Dec 07, 2012
AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
K122760 · DTM
Medtronic, Inc.
Cardiovascular · 88d
Cleared Dec 07, 2012
REVERSE MEDICAL MICROCATHETER
K122684 · DQY
Reverse Medical Corporation
Cardiovascular · 98d
Cleared Dec 07, 2012
FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE
K122330 · JOW
Arjohuntleigh Polska SP Z.O.O.
Cardiovascular · 127d
Cleared Dec 07, 2012
SMI CARDIOVASCULAR PATCH
K122105 · DXZ
Solinas Medical, Inc.
Cardiovascular · 143d
Cleared Dec 06, 2012
QT GUARD PLUS ANALYSIS SYSTEM
K120770 · DPS
Ge Medical Systems Information...
Cardiovascular · 267d
Cleared Dec 05, 2012
MOBILE CAREGUIDE 2100 OXIMETER
K122645 · MUD
Reflectance Medical, Inc.
Cardiovascular · 97d
Cleared Dec 05, 2012
MERIT ONE SNARE SYSTEM
K122088 · MMX
Merit Medical Systems, Inc.
Cardiovascular · 142d
Cleared Nov 28, 2012
AZUR CX DETACHABLE 18
K123384 · KRD
MicroVention, Inc.
Cardiovascular · 26d
Cleared Nov 28, 2012
SEAL ONE
K123035 · DXC
Perouse Medical
Cardiovascular · 61d
Cleared Nov 28, 2012
BLIP MODEL BP-700WF
K123020 · DXN
Carematix, Inc.
Cardiovascular · 61d
Cleared Nov 28, 2012
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL...
K122543 · KRD
MicroVention, Inc.
Cardiovascular · 99d
Cleared Nov 28, 2012
SJM CONFIRM
K122161 · MXC
St Jude Medical
Cardiovascular · 131d
Cleared Nov 27, 2012
MULTICROSS SUPPORT CATHETER
K121763 · DQY
Roxwood Medical, Inc.
Cardiovascular · 165d
Cleared Nov 21, 2012
MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254
K122581 · DQY
Concentric Medical, Inc.
Cardiovascular · 90d
Cleared Nov 20, 2012
REMOTE PRESENCE SYSTEM, MODEL RP-VITA
K123229 · DRG
Intouch Health, Inc.
Cardiovascular · 36d
Cleared Nov 20, 2012
CDI BLOOD PARAMETER MONITORING SYSTEM 500
K123039 · DRY
Terumo Cardiovascular Systems Corp.
Cardiovascular · 53d