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
3985–4008 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 16, 2014
INSERTION TOOL
K140673 · DQX
Boston Scientific Corp
Cardiovascular · 29d
Cleared Apr 16, 2014
ROTATING ADAPTERS
K140475 · DTL
Merit Medical Systems, Inc.
Cardiovascular · 49d
Cleared Apr 16, 2014
TRUEPATH CTO DEVICE
K140288 · PDU
Boston Scientific Corp
Cardiovascular · 70d
Cleared Apr 16, 2014
CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES)
K140092 · JOW
Currie Medical Specialties, Inc.
Cardiovascular · 92d
Cleared Apr 14, 2014
MYHEALTHPOINT TELEHEALTH MANAGER
K132930 · DRG
Entra Health Systems
Cardiovascular · 208d
Cleared Apr 11, 2014
MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLET
K133923 · MUD
Reflectance Medical, Inc.
Cardiovascular · 109d
Cleared Apr 10, 2014
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
K140339 · MWI
Covidien
Cardiovascular · 59d
Cleared Apr 10, 2014
1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
K140042 · MGZ
LeMaitre Vascular, Inc.
Cardiovascular · 92d
Cleared Apr 10, 2014
BIO-PROBE TRANSDUCER (ADULT)
K133903 · DPT
Medtronic, Inc.
Cardiovascular · 111d
Cleared Apr 09, 2014
LEXICONTURE MECHANICAL DILATOR SHEATH SET
K140047 · DRE
Spectranetics Corp.
Cardiovascular · 90d
Cleared Apr 07, 2014
HYDROPHILIC COATED GUIDEWIRE
K133155 · DQX
Lake Region Medical
Cardiovascular · 172d
Cleared Apr 04, 2014
CLOUDEKG
K130878 · DXH
Makromed, Inc.
Cardiovascular · 371d
Cleared Apr 03, 2014
ACUITY PRO LEAD DELIVERY SYSTEM
K132914 · DQY
Boston Scientific
Cardiovascular · 198d
Cleared Apr 03, 2014
ZOLL CODE WRITER
K132488 · DXJ
ZOLL Medical Corporation
Cardiovascular · 238d
Cleared Apr 03, 2014
VITALCONNECT PLATFORM BY VITAL CONNECT INC.
K132447 · DRG
Vitalconnect, Inc.
Cardiovascular · 240d
Cleared Apr 01, 2014
VADO STEERABLE SHEATH
K140420 · DYB
Kalila Medical, Inc.
Cardiovascular · 42d
Cleared Mar 31, 2014
EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM
K134044 · DQK
Cardio Tek, BV
Cardiovascular · 90d
Cleared Mar 28, 2014
AXERA 2 ACCESS SYSTEM
K140201 · DYB
Arstasis, Inc.
Cardiovascular · 60d
Cleared Mar 27, 2014
MANDREL GUIDEWIRE
K140485 · DQX
Lake Region Medical
Cardiovascular · 29d
Cleared Mar 27, 2014
LEXIPLIANT DILATOR SHEATH SET
K133631 · DRE
Spectranetics Corporation
Cardiovascular · 121d
Cleared Mar 26, 2014
PEREGRINE SYSTEM INFUSION CATHETER
K140637 · KRA
Ablative Solutions, Inc.
Cardiovascular · 14d
Cleared Mar 26, 2014
TOTAL ACROSS
K133539 · DQY
Medtronic Vascular
Cardiovascular · 128d
Cleared Mar 24, 2014
WITHINGS BLOOD PRESURE MONITOR
K133125 · DXN
Withings
Cardiovascular · 175d
Cleared Mar 20, 2014
IM60/IM70 PATIENT MONITOR
K131971 · MHX
Edan Instruments, Inc.
Cardiovascular · 265d