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
7993–8016 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 20, 2003
REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200
K024243 · MCW
Fox Hollow Technologies
Cardiovascular · 179d
Cleared Jun 20, 2003
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
K030944 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 86d
Cleared Jun 19, 2003
PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV
K031164 · DTD
Oscor, Inc.
Cardiovascular · 66d
Cleared Jun 18, 2003
ULTRA HIGH PRESSURE INJECTOR LINES
K023591 · DQO
Deroyal Industries, Inc.
Cardiovascular · 236d
Cleared Jun 18, 2003
LUMEND FRONTRUNNER GW CTO CATHETER
K031005 · PDU
Lumend, Inc.
Cardiovascular · 79d
Cleared Jun 16, 2003
MODIFICATION TO IVS INTRODUCER SET, MODEL 1003
K031583 · DYB
Integrated Vascular Systems, Inc.
Cardiovascular · 26d
Cleared Jun 11, 2003
GALIX PACESTAR
K023080 · DTE
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 267d
Cleared Jun 11, 2003
DISPOSABLE TEMPORARY PACING WIRE
K023174 · LDF
River Medical, Inc.
Cardiovascular · 261d
Cleared Jun 11, 2003
PRIME ECG SYSTEM
K030104 · DPS
Meridian Medical Technologies, Inc.
Cardiovascular · 149d
Cleared Jun 11, 2003
EKGCARD SYSTEM
K030535 · DPS
Qrs Diagnostic, LLC
Cardiovascular · 111d
Cleared Jun 11, 2003
IQMARK DIGITAL HOLTER
K031466 · MLO
Brentwood Medical Technology Corp.
Cardiovascular · 34d
Cleared Jun 10, 2003
DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
K031569 · DSP
Datascope Corp.
Cardiovascular · 21d
Cleared Jun 06, 2003
GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100
K022926 · DXN
Genteel Technology Co., Ltd.
Cardiovascular · 306d
Cleared Jun 06, 2003
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
K030738 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 88d
Cleared Jun 06, 2003
AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL...
K031479 · DXN
Datex-Ohmeda, Inc.
Cardiovascular · 29d
Cleared Jun 06, 2003
PRESSURE WIRE SENSOR, MODELS 12004/12304
K031662 · DXO
Radi Medical Systems AB
Cardiovascular · 9d
Cleared Jun 04, 2003
BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC
K023691 · NFA
Boston Scientific Epi
Cardiovascular · 215d
Cleared Jun 04, 2003
SHELHIGH BIORING
K023940 · KRH
Shelhigh, Inc.
Cardiovascular · 190d
Cleared Jun 03, 2003
MAGLIFE C/MAGLIFE C PLUS
K023195 · MWI
Schiller Medical S.A.
Cardiovascular · 251d
Cleared Jun 03, 2003
ARTERIALFLOW SYSTEM, MODEL 32A
K024019 · JOW
Aircast, Inc.
Cardiovascular · 180d
Cleared Jun 03, 2003
LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0
K031000 · DQK
C.R. Bard, Inc.
Cardiovascular · 64d
Cleared May 30, 2003
EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP
K030587 · DRN
S-Tct Health, Inc.
Cardiovascular · 94d
Cleared May 30, 2003
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING
K030726 · DTN
Gish Biomedical, Inc.
Cardiovascular · 84d
Cleared May 30, 2003
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1
K031403 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 25d