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
5521–5544 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 25, 2010
BLOOD PRESSURE METER MODEL CH-101
K100553 · DXN
Citizen Systems Japan Co., Ltd.
Cardiovascular · 88d
Cleared May 25, 2010
CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)
K092021 · OHA
Cryolife, Inc.
Cardiovascular · 323d
Cleared May 24, 2010
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL
K101011 · DQX
Abbott Vascular, Inc.
Cardiovascular · 42d
Cleared May 24, 2010
POLYTEL(R) APT MODEL: PWA-08-01
K100524 · DRG
Polymap Wireless, LLC
Cardiovascular · 89d
Cleared May 21, 2010
GUARDIAN II NC HEMOSTASIS VALVE
K101113 · DTL
Zerusa Limited
Cardiovascular · 30d
Cleared May 20, 2010
LYMPHA PRESS 201MAX, MODEL 201MAX
K100677 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 71d
Cleared May 20, 2010
ALLY PLATFORM SYSTEM
K093895 · DRG
Continuity Health Solutions
Cardiovascular · 153d
Cleared May 19, 2010
JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100
K100462 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 90d
Cleared May 19, 2010
TERUMO LAUER LOCK ADAPTER
K093992 · DTL
Terumo Cardiovascular Systems...
Cardiovascular · 146d
Cleared May 14, 2010
COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS
K100521 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 80d
Cleared May 12, 2010
GLIDER PTA BALLOON CATHETER
K101062 · LIT
Trireme Medical, Inc.
Cardiovascular · 26d
Cleared May 12, 2010
NAVIGATOR CLINICAL GUIDENCE SYSTEM
K092219 · DXG
Applied Physiology Pty , Ltd.
Cardiovascular · 294d
Cleared May 11, 2010
TEMPUS IC PROFESSIONAL PATIENT MONITOR
K101264 · MWI
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 6d
Cleared May 11, 2010
INTELLIVUE PATIENT MONITOR
K093268 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 204d
Cleared May 10, 2010
BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM
K101078 · DRG
Bl Healthcare, Inc.
Cardiovascular · 21d
Cleared May 10, 2010
MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L...
K100274 · DWF
Medtronic, Inc.
Cardiovascular · 101d
Cleared May 10, 2010
OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE
K093813 · KRD
Imbiotechnologies
Cardiovascular · 150d
Cleared May 10, 2010
INTCO TAB ELECTRODE
K093327 · DRX
Shanghai Intco Electrode...
Cardiovascular · 196d
Cleared May 07, 2010
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065,...
K101067 · MHX
Philips Medical Systems
Cardiovascular · 21d
Cleared May 07, 2010
VITALOGIK 6000/6500
K093766 · DSI
Mennen Medical , Ltd.
Cardiovascular · 151d
Cleared May 07, 2010
BLOOD PRESSURE MONITOR/ MODELS
K093739 · DXN
Ningbo Diaier Electronic Co., Ltd.
Cardiovascular · 154d
Cleared May 06, 2010
A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH
K092097 · DYB
A.B. Korkor Medical, Inc.
Cardiovascular · 296d
Cleared May 05, 2010
CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B
K100508 · DRG
Carematix, Inc.
Cardiovascular · 72d
Cleared May 04, 2010
ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY...
K100523 · NMD
Hygia Health Services, Inc.
Cardiovascular · 69d