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
6673–6696 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 15, 2007
MORTARA ELI 10 ELECTROCARDIOGRAPH
K070539 · DPS
Mortara Instrument, Inc.
Cardiovascular · 17d
Cleared Mar 15, 2007
CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001
K070448 · NQH
Cardiomems, Inc.
Cardiovascular · 28d
Cleared Mar 15, 2007
REPROCESSED HEART STABILIZERS AND POSITIONERS
K063844 · NQG
Sterilmed, Inc.
Cardiovascular · 79d
Cleared Mar 15, 2007
SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
K063490 · DQK
Spacelabs Medical, Inc.
Cardiovascular · 118d
Cleared Mar 15, 2007
ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488
K063210 · DQX
Medtronic Inc. Cardiac Rhythm Management
Cardiovascular · 143d
Cleared Mar 14, 2007
MODIFICATION TO HYPERTRANSIT INFUSION CATHETER
K070279 · KRA
Cordis Neurovascular, Inc.
Cardiovascular · 44d
Cleared Mar 13, 2007
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02
K070421 · MSX
Ge Healthcare
Cardiovascular · 28d
Cleared Mar 13, 2007
TENDERFLOW PERIATRIC ARTERIAL CANNULA
K063618 · DWF
Terumo Cardiovascular Systems Corp.
Cardiovascular · 98d
Cleared Mar 07, 2007
BP-200 PLUS
K063814 · DXN
Schiller AG
Cardiovascular · 75d
Cleared Mar 07, 2007
CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION...
K063563 · LIT
Cordis Europa, N.V.
Cardiovascular · 99d
Cleared Feb 28, 2007
AMPLATZER RELIANT CATHETER DELIVERY SYSTEM
K070238 · DQY
Aga Medical Corp.
Cardiovascular · 34d
Cleared Feb 28, 2007
D-STAT HANDLE, MODEL 8500-053
K063871 · DXC
Vascular Solutions, Inc.
Cardiovascular · 61d
Cleared Feb 28, 2007
CRITIVIEW, MODEL CRV3
K062977 · DPW
Critisense , Ltd.
Cardiovascular · 152d
Cleared Feb 28, 2007
ZOLL M SERIES WITH REAL CPR HELP
K062537 · MKJ
ZOLL Medical Corporation
Cardiovascular · 183d
Cleared Feb 23, 2007
CARDIODAY, VERSION 2.0
K070280 · DQK
Getemed Medizin- Und...
Cardiovascular · 25d
Cleared Feb 23, 2007
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0
K070260 · DSI
Philips Medical Systems
Cardiovascular · 28d
Cleared Feb 23, 2007
ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY
K070197 · DYB
Acumen Medical, Inc.
Cardiovascular · 32d
Cleared Feb 23, 2007
BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870
K062852 · DYB
Onset Medical Corporation
Cardiovascular · 151d
Cleared Feb 16, 2007
CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR
K063349 · DXZ
Cormatrix Cardiovascular, Inc.
Cardiovascular · 102d
Cleared Feb 16, 2007
INFINITY TELESMART TELEMETRY SYSTEM
K061379 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 275d
Cleared Feb 15, 2007
TEMPORARY LIMB SALVAGE SHUNT
K070323 · DXC
Vascutek, Ltd.
Cardiovascular · 13d
Cleared Feb 15, 2007
VASCUPUNCTURE PICC GUIDEWIRE
K070150 · DQX
Neometrics, Inc.
Cardiovascular · 30d
Cleared Feb 14, 2007
SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING
K062569 · DXC
Datascope Corp.
Cardiovascular · 167d
Cleared Feb 08, 2007
MP5 INTELLIVUE PATIENT MONITOR
K063725 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 55d