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
4489–4512 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 04, 2013
ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER
K122854 · DYB
Arrow International (Subsidiary of...
Cardiovascular · 108d
Cleared Jan 04, 2013
DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
K113787 · MKJ
Defibtech, LLC
Cardiovascular · 379d
Cleared Jan 03, 2013
RETRACTA DETACHABLE EMBOLIZATION COIL
K123712 · KRD
Cook Incorporated
Cardiovascular · 30d
Cleared Jan 03, 2013
TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT,...
K123452 · DQY
Stryker
Cardiovascular · 56d
Cleared Jan 03, 2013
JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088
K123194 · DXC
North American Rescue Products, Inc.
Cardiovascular · 84d
Cleared Jan 03, 2013
MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER
K122943 · DPT
Moor Instruments, Ltd.
Cardiovascular · 101d
Cleared Jan 03, 2013
DOPPLEX ABILITY
K121108 · JOM
Huntleigh Healthcare
Cardiovascular · 266d
Cleared Dec 27, 2012
FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)
K123591 · DRA
Medtronic Cryocath, LP
Cardiovascular · 36d
Cleared Dec 21, 2012
TRANSTEK WRIST BLOOD PRESSURE MONITOR
K123669 · DXN
Zhongshan Transtek Electronics Co., Ltd.
Cardiovascular · 22d
Cleared Dec 21, 2012
VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003
K122609 · JOW
Venous Health Systems, Inc.
Cardiovascular · 116d
Cleared Dec 21, 2012
NHANCER
K121077 · DQY
Imds Operations B.V.
Cardiovascular · 256d
Cleared Dec 20, 2012
HEALTHVIEW ECG MANAGER
K123466 · DQK
Lumedx
Cardiovascular · 41d
Cleared Dec 20, 2012
REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER
K121913 · OWQ
Stryker Sustainability Solutions, Inc.
Cardiovascular · 171d
Cleared Dec 19, 2012
MOBICATH TRANSSEPTAL NEEDLE
K122832 · DRC
Great Batch Medical
Cardiovascular · 93d
Cleared Dec 19, 2012
BASIXCONPAK ANALOG INFLATION SYRINGE
K122321 · MAV
Merit Medical Ireland, Ltd.
Cardiovascular · 140d
Cleared Dec 18, 2012
HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
K122813 · DWC
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 96d
Cleared Dec 14, 2012
OCELOT PIXL CATHETER
K123532 · PDU
Avinger, Inc.
Cardiovascular · 28d
Cleared Dec 14, 2012
UNBALLOON NON-OCCLUSIVE MODELING CATHETER
K123531 · DQY
LeMaitre Vascular, Inc.
Cardiovascular · 28d
Cleared Dec 14, 2012
SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT...
K122937 · DQO
Cook, Inc.
Cardiovascular · 81d
Cleared Dec 14, 2012
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE...
K122827 · DTZ
Medtronic, Inc.
Cardiovascular · 91d
Cleared Dec 14, 2012
OXTI INFLATION DEVICE
K122152 · MAV
Oxti Corporation
Cardiovascular · 147d
Cleared Dec 13, 2012
AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY...
K123448 · DTL
Medtronic, Inc.
Cardiovascular · 35d
Cleared Dec 13, 2012
GORE FLOW REVERSAL SYSTEM MODEL GFRS073
K123156 · NTE
W.L. Gore & Associates, Inc.
Cardiovascular · 65d
Cleared Dec 13, 2012
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
K122960 · DYB
Oscor, Inc.
Cardiovascular · 79d