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
8137–8160 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 24, 2003
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
K023878 · NFA
Medtronic Vascular
Cardiovascular · 64d
Cleared Jan 24, 2003
NITREX NITINOL GUIDEWIRE
K024021 · DQX
Ev3 Corporation
Cardiovascular · 50d
Cleared Jan 24, 2003
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
K030019 · DQX
Guidant Corp.
Cardiovascular · 21d
Cleared Jan 23, 2003
LUMEND FRONTRUNNER CTO CATHETER
K023114 · PDU
Lumend, Inc.
Cardiovascular · 126d
Cleared Jan 23, 2003
RAPID THERMAL EXCHANGE SYSTEM
K023934 · DWJ
Avacore Technologies, Inc.
Cardiovascular · 58d
Cleared Jan 21, 2003
INNER-LOCK LOCKING INTRODUCER SHEATHS
K022170 · DYB
Rex Medical
Cardiovascular · 202d
Cleared Jan 17, 2003
CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM
K023689 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 77d
Cleared Jan 17, 2003
SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G
K023745 · DTX
Sechrist Industries, Inc.
Cardiovascular · 71d
Cleared Jan 16, 2003
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
K023356 · DXQ
Card Guard Scientific Survival , Ltd.
Cardiovascular · 101d
Cleared Jan 16, 2003
ENCLOSE ANASTOMOSIS ASSIST DEVICE
K023682 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 76d
Cleared Jan 16, 2003
SKINTACT
K023920 · DRX
Leonhard Lang GmbH
Cardiovascular · 52d
Cleared Jan 16, 2003
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
K024247 · DRX
Leonhard Lang GmbH
Cardiovascular · 24d
Cleared Jan 16, 2003
SKINTACT
K024264 · DRX
Leonhard Lang Co.
Cardiovascular · 24d
Cleared Jan 15, 2003
STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM
K021555 · DXX
Stereotaxis, Inc.
Cardiovascular · 247d
Cleared Jan 15, 2003
TM2005 PERSONAL MEDICAL PHONE CENTER
K024365 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 15d
Cleared Jan 14, 2003
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
K022145 · DXE
LeMaitre Vascular, Inc.
Cardiovascular · 196d
Cleared Jan 14, 2003
HL888
K023834 · DXN
Health & Life Co., Ltd.
Cardiovascular · 57d
Cleared Jan 14, 2003
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
K024126 · DQO
Abbott Laboratories
Cardiovascular · 29d
Cleared Jan 14, 2003
PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS,...
K024156 · DTD
Oscor, Inc.
Cardiovascular · 28d
Cleared Jan 10, 2003
SOLA, COUNTER-PULSATION, MODEL SECP-S
K022078 · DRN
Sola Medical Devices, LLC
Cardiovascular · 198d
Cleared Jan 10, 2003
MEDRAD STELLANT CT INJECTOR SYSTEM
K023183 · DXT
Medrad, Inc.
Cardiovascular · 108d
Cleared Jan 09, 2003
JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS
K020784 · DWF
Jostra AG
Cardiovascular · 304d
Cleared Jan 09, 2003
CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM
K020863 · DQK
Biosense Webster, Inc.
Cardiovascular · 297d
Cleared Jan 09, 2003
NIKOMED TRACE 1 ECG ELECTRODES
K022909 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 128d