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
9265–9288 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 01, 2000
CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS...
K993189 · DWE
Terumo Corp.
Cardiovascular · 160d
Cleared Mar 01, 2000
MIKRO-TIP ANGIOGRAPHIC CATHETER
K993694 · DQO
Millar Instruments, Inc.
Cardiovascular · 120d
Cleared Feb 28, 2000
MODIFICATION TO T-REX BIOPSY FORCEPS
K000409 · DWZ
Boston Scientific Corp
Cardiovascular · 20d
Cleared Feb 28, 2000
ZOLL M SERIES ETCO2 OPTION
K993036 · MKJ
Zoll Medical Corp
Cardiovascular · 172d
Cleared Feb 25, 2000
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA...
K000430 · DTZ
Medtronic Vascular
Cardiovascular · 16d
Cleared Feb 25, 2000
CLEEN-ABLE
K994044 · DXQ
Vital Signs, Inc.
Cardiovascular · 88d
Cleared Feb 25, 2000
VERIPATH PERIPHERAL GUIDING CATHETER
K994229 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 71d
Cleared Feb 24, 2000
DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400
K992638 · MWI
Critikon Company, LLC
Cardiovascular · 202d
Cleared Feb 23, 2000
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT
K000210 · DTD
Medtronic Vascular
Cardiovascular · 30d
Cleared Feb 22, 2000
LEMAITRE BALLOON CATHETER WITH IRRIGATION
K992940 · DXE
Vascutech, Inc.
Cardiovascular · 175d
Cleared Feb 22, 2000
SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR
K993974 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 90d
Cleared Feb 18, 2000
IBC VRV, MODEL 1350
K992657 · DWD
International Biophysics Corp.
Cardiovascular · 193d
Cleared Feb 18, 2000
8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
K993966 · DSP
Arrow Intl., Inc.
Cardiovascular · 87d
Cleared Feb 17, 2000
SJM TAILOR ANNULOPLASTY RING, MODEL TARN
K000119 · KRH
St. Jude Medical, Inc.
Cardiovascular · 30d
Cleared Feb 17, 2000
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.)...
K991737 · DTZ
Dideco S.P.A.
Cardiovascular · 272d
Cleared Feb 16, 2000
MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA...
K000379 · DTM
Medtronic Vascular
Cardiovascular · 9d
Cleared Feb 16, 2000
ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION
K981936 · DQX
Advanced Biomedical Devices, Inc.
Cardiovascular · 624d
Cleared Feb 11, 2000
CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306
K000225 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 18d
Cleared Feb 11, 2000
KODAK HOME HEALTH MONITORING SYSTEM
K983928 · MWI
Eastman Kodak Company
Cardiovascular · 463d
Cleared Feb 10, 2000
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER
K000101 · LIT
Guidant Corp.
Cardiovascular · 28d
Cleared Feb 10, 2000
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE
K000274 · DWF
Medtronic Cardiac Surgical Products
Cardiovascular · 10d
Cleared Feb 08, 2000
ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE
K993818 · DWF
California Medical Laboratories, Inc.
Cardiovascular · 90d
Cleared Feb 03, 2000
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS...
K993383 · DSI
Hewlett-Packard GmbH
Cardiovascular · 118d
Cleared Feb 03, 2000
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80
K993745 · MKJ
Katecho, Inc.
Cardiovascular · 90d