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
7969–7992 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 15, 2003
CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF
K031416 · DXQ
Clearmedical, Inc.
Cardiovascular · 71d
Cleared Jul 12, 2003
KAMAR ANNULUS DILATOR + SIZER
K030788 · DWP
Geister Medizin Technik GmbH
Cardiovascular · 122d
Cleared Jul 11, 2003
MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE
K030547 · DRL
Guardian Angel Products, Inc.
Cardiovascular · 141d
Cleared Jul 11, 2003
OPTIBOLUS
K031339 · DXT
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 74d
Cleared Jul 11, 2003
ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1
K031417 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 67d
Cleared Jul 10, 2003
4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX,...
K030852 · DRF
Mogul Enterprises
Cardiovascular · 114d
Cleared Jul 10, 2003
BODY SIGNAL ECG ELECTRODE
K031174 · DRX
Wandy Rubber Industrial Co., Ltd.
Cardiovascular · 87d
Cleared Jul 09, 2003
TELZUIT CARDIAC MONITORING SYSTEM
K031229 · DXH
Telzuit Technologies, Inc.
Cardiovascular · 82d
Cleared Jul 09, 2003
IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD...
K032040 · KFM
Dideco S.P.A.
Cardiovascular · 8d
Cleared Jul 03, 2003
PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS...
K031422 · DPS
Philips Medical Systems
Cardiovascular · 58d
Cleared Jul 02, 2003
RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE
K031688 · DTL
Guidant Corporation
Cardiovascular · 30d
Cleared Jul 02, 2003
ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX
K031827 · DWF
Medtronic Perfusion Systems
Cardiovascular · 19d
Cleared Jul 01, 2003
HL168R
K031695 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Jul 01, 2003
HL888RA
K031835 · DXN
Health & Life Co., Ltd.
Cardiovascular · 29d
Cleared Jun 30, 2003
CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000
K024323 · MLO
Biomedical Systems Corp.
Cardiovascular · 186d
Cleared Jun 26, 2003
METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON...
K024000 · DQO
Angiometrx, Inc.
Cardiovascular · 204d
Cleared Jun 26, 2003
TS3 TUBING SET
K031151 · DWF
Global Blood Resources, LLC
Cardiovascular · 77d
Cleared Jun 26, 2003
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K031766 · DQY
Cook, Inc.
Cardiovascular · 17d
Cleared Jun 25, 2003
RAPIDO CUT-AWAY GUIDING CATHETER
K031505 · DQY
Guidant Corporation
Cardiovascular · 42d
Cleared Jun 25, 2003
DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES
K031781 · MHX
Datex-Ohmeda
Cardiovascular · 15d
Cleared Jun 24, 2003
NITREX NITINOL GUIDEWIRE
K031864 · DQX
Ev3 Corporation
Cardiovascular · 8d
Cleared Jun 23, 2003
PER, MODEL MEMO
K030218 · DXH
Medical Monitors Pty., Ltd.
Cardiovascular · 153d
Cleared Jun 23, 2003
HEMOBAG, MODEL HBBSD2000
K031150 · DTN
Global Blood Resources, LLC
Cardiovascular · 74d
Cleared Jun 23, 2003
JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900
K031346 · OBJ
Jomed, Inc.
Cardiovascular · 55d