FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,027 results
10585–10608 of 18,027
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 01, 1995
ANGIOPTIC ANGIOGRAPHIC CATHETER
K954423 · DQO
AngioDynamics, Inc.
Cardiovascular · 71d
Cleared Nov 30, 1995
DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM
K953651 · DRF
Arrow Intl., Inc.
Cardiovascular · 118d
Cleared Nov 29, 1995
CARBOMEDICS SUPRA-ANNULAR VALVE SIZER
K952184 · DTI
Carbomedics, Inc.
Cardiovascular · 204d
Cleared Nov 28, 1995
DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY...
K954317 · DYB
Daig Corp.
Cardiovascular · 74d
Cleared Nov 27, 1995
NIHON KOHDEN WEP-8430A CENTRAL TELEMETRY SYSTEM
K945944 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 357d
Cleared Nov 27, 1995
SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION...
K951566 · DYG
Baxter Healthcare Corp
Cardiovascular · 237d
Cleared Nov 27, 1995
RADIFOCUS INTRODUCER II KIT
K954234 · DYB
Terumo Medical Corp.
Cardiovascular · 77d
Cleared Nov 22, 1995
NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER
K946175 · DRG
Nihon Kohden America, Inc.
Cardiovascular · 338d
Cleared Nov 22, 1995
BODYSTAY
K951097 · DSB
Bodystat , Ltd.
Cardiovascular · 259d
Cleared Nov 22, 1995
CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER
K953768 · DRF
Cordis Webster, Inc.
Cardiovascular · 100d
Cleared Nov 21, 1995
MEDTRONIC GC IV CORONARY GUIDING CATHETER
K950490 · DQY
Medtronics Interventional Vascular
Cardiovascular · 288d
Cleared Nov 20, 1995
OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS
K945138 · DXN
Invivo Research, Inc.
Cardiovascular · 396d
Cleared Nov 20, 1995
CAD-2000 CARDIAC ASSIST DEVICE
K951124 · DRM
Eee Medical Ent.
Cardiovascular · 269d
Cleared Nov 17, 1995
ENTERPRISE
K935998 · DQX
Camp Intl., Inc.
Cardiovascular · 702d
Cleared Nov 17, 1995
3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION...
K950739 · DWA
3M Health Care, Sarns
Cardiovascular · 273d
Cleared Nov 17, 1995
MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL...
K954391 · DRL
Bio-Tek Instruments, Inc.
Cardiovascular · 59d
Cleared Nov 17, 1995
K-DEFIB/PACE PEDIATRIC ELECTRODE
K954504 · MKJ
Katecho, Inc.
Cardiovascular · 50d
Cleared Nov 14, 1995
NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER
K945578 · DRG
Nihon Kohden America, Inc.
Cardiovascular · 365d
Cleared Nov 14, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM
K950472 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 284d
Cleared Nov 14, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540
K950475 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 284d
Cleared Nov 14, 1995
XXL BALLON DILATATION CATHETER
K952063 · LIT
Boston Scientific Corp
Cardiovascular · 196d
Cleared Nov 13, 1995
SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETER
K953909 · DQY
Scimed
Cardiovascular · 84d
Cleared Nov 09, 1995
HEARTHWATCH III(TM)
K945476 · DXH
Instromedix, Inc.
Cardiovascular · 366d
Cleared Nov 07, 1995
EDM
K951369 · DPW
Deltex Medical
Cardiovascular · 225d