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
8401–8424 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 08, 2002
MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B
K021300 · DSI
Philips Medical Systems
Cardiovascular · 14d
Cleared May 07, 2002
ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.
K021251 · DSI
Philips Medical Systems
Cardiovascular · 18d
Cleared May 07, 2002
TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
K021287 · DTN
Medtronic Perfusion Systems
Cardiovascular · 14d
Cleared May 07, 2002
MODIFICATION OF APEXPRO TELEMETRY SYSTEM
K021325 · MHX
General Electric Medical Systems...
Cardiovascular · 11d
Cleared May 07, 2002
MODIFICATION TO M2376A DEVICELINK SYSTEM
K021347 · MWI
Philips Medical Systems
Cardiovascular · 8d
Cleared May 03, 2002
3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE
K020365 · KRI
3t Medical Systems, LLC
Cardiovascular · 88d
Cleared May 02, 2002
TRANSSEPTAL NEEDLE/TROCAR
K011727 · DRC
Thomas Medical Products, Inc.
Cardiovascular · 332d
Cleared May 02, 2002
TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING...
K013484 · DRF
Stereotaxis, Inc.
Cardiovascular · 195d
Cleared May 02, 2002
JOGUIDE CARDIOVASCULAR GUIDING C ATHETER
K021088 · DQY
Jomed Catheter, Inc.
Cardiovascular · 28d
Cleared May 02, 2002
RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL...
K021120 · DQY
Arrow Intl., Inc.
Cardiovascular · 24d
Cleared May 02, 2002
LV-1 HEMOSTASIS VALVE, MODEL #6789
K021282 · DTL
Guidant Corp.
Cardiovascular · 14d
Cleared May 02, 2002
GUIDANT BALLOON CATHETER, SEVERAL MODELS
K021283 · DQO
Guidant Corp.
Cardiovascular · 14d
Cleared May 02, 2002
EASYTRAK GUIDING CATHETER
K021284 · DQY
Guidant Corp.
Cardiovascular · 14d
Cleared May 02, 2002
HI-TORQUE EXTRA S'PORT GUIDEWIRE
K021285 · DQX
Guidant Corp.
Cardiovascular · 14d
Cleared May 01, 2002
KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS
K011859 · DWJ
Klimamed Technologie Medizingerate GmbH
Cardiovascular · 321d
Cleared May 01, 2002
KENDALL, SEQUENTIAL COMPRESSION DEVICE
K012614 · JOW
Medical Instruments Technology, Inc.
Cardiovascular · 261d
Cleared May 01, 2002
AROX 53-BP
K021217 · DTB
Biotronik, Inc.
Cardiovascular · 14d
Cleared Apr 30, 2002
GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
K020366 · DPS
Cardiocomm Solutions, Inc.
Cardiovascular · 85d
Cleared Apr 26, 2002
ACIST PLUS 4 ANGIOGRAPHIC CATHETER
K021015 · DQO
Acist Medical Systems
Cardiovascular · 28d
Cleared Apr 25, 2002
COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE
K010128 · DYB
Cook Vascular, Inc.
Cardiovascular · 464d
Cleared Apr 25, 2002
10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600
K013517 · DQY
Medtronic Vascular
Cardiovascular · 185d
Cleared Apr 25, 2002
ATRION MEDICAL QL FLUID DISPENSING SYRINGE
K020333 · DXT
Atrion Medical Products, Inc.
Cardiovascular · 84d
Cleared Apr 25, 2002
PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES
K020708 · DPS
Philips Medical Systems, Inc.
Cardiovascular · 51d
Cleared Apr 24, 2002
DATASCOPE'S 8FR. ALT B IAB
K020257 · DSP
Datascope Corp.
Cardiovascular · 90d