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
8185–8208 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 10, 2002
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
K023320 · DQY
Guidant Corp.
Cardiovascular · 67d
Cleared Dec 04, 2002
NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE
K023016 · DRN
Nicore Equipment & Leasing, Inc.
Cardiovascular · 85d
Cleared Dec 04, 2002
PEDIATRIC ARTERIAL CANNULA
K023251 · DWF
Polystan A/S
Cardiovascular · 65d
Cleared Dec 04, 2002
PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE
K023700 · DQX
Precision Vascular Systems, Inc.
Cardiovascular · 30d
Cleared Dec 04, 2002
M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE...
K023871 · MHX
Philips Medical Systems
Cardiovascular · 14d
Cleared Dec 03, 2002
NEWCOR
K020440 · DQK
Siemens Medical Systems, Inc.
Cardiovascular · 295d
Cleared Dec 03, 2002
T-WAVE ALTERMANS (TWA) ALGORITHM OPTION
K023380 · DQK
General Electric Medical Systems...
Cardiovascular · 56d
Cleared Dec 03, 2002
MODIFICATION TO ENVOY PATIENT MONITOR
K023798 · DSI
Mennen Medical , Ltd.
Cardiovascular · 19d
Cleared Dec 02, 2002
SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA...
K022640 · MCW
Bacchus Vascular, Inc.
Cardiovascular · 116d
Cleared Dec 02, 2002
TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION...
K023514 · QEY
Bacchus Vascular, Inc.
Cardiovascular · 42d
Cleared Nov 29, 2002
PHILIPS DRUG CALCULATOR SOFTWARE
K023674 · MHX
Philips Medical Systems
Cardiovascular · 28d
Cleared Nov 27, 2002
ENDOVASCULAR GUIDE WIRE
K021363 · DQX
Stereotaxis, Inc.
Cardiovascular · 211d
Cleared Nov 27, 2002
RECOVERY FILTER SYSTEM, MODEL RF-048F
K022236 · DTK
C.R. Bard, Inc.
Cardiovascular · 139d
Cleared Nov 27, 2002
CHILLBUSTER
K022903 · DWJ
Microtek Medical, Inc.
Cardiovascular · 85d
Cleared Nov 27, 2002
ADAPTERS WITH X-COATING
K022918 · DTL
Terumo Cardiovascular Systems...
Cardiovascular · 84d
Cleared Nov 26, 2002
CIRCUIT TUBINGS WITH X-COATING
K023056 · DWF
Terumo Cardiovascular Systems Corp.
Cardiovascular · 74d
Cleared Nov 26, 2002
RENEGADE STC 18 MICROCATHETER
K023681 · DQO
Boston Scientific Corp
Cardiovascular · 25d
Cleared Nov 21, 2002
BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211
K022916 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 79d
Cleared Nov 21, 2002
WIZAIR COMPRESSION SYSTEM
K023573 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 28d
Cleared Nov 21, 2002
STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35
K023622 · DWF
Stockert Instrumente GmbH
Cardiovascular · 23d
Cleared Nov 19, 2002
TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM
K022783 · DXN
Tensys Medical, Inc.
Cardiovascular · 89d
Cleared Nov 19, 2002
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O
K023698 · MHX
Philips Medical Systems
Cardiovascular · 15d
Cleared Nov 19, 2002
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B)
K023749 · DRG
Philips Medical Systems
Cardiovascular · 11d
Cleared Nov 15, 2002
PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
K013913 · NFA
Medtronic Percusurge, Inc.
Cardiovascular · 353d