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
8113–8136 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 19, 2003
MCPULSE
K023238 · JOM
Meridian Co., Ltd.
Cardiovascular · 145d
Cleared Feb 19, 2003
CVSI PERIPHERAL BALLOON CATHETER
K023463 · DQY
Cryo Vascular Systems, Inc.
Cardiovascular · 127d
Cleared Feb 14, 2003
EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS...
K022071 · DTM
Embol-X, Inc.
Cardiovascular · 233d
Cleared Feb 14, 2003
STEERABLE GUIDEWIRE
K022813 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 172d
Cleared Feb 14, 2003
SAMARITAN AED, MODEL SAM-01
K023854 · MKJ
Heartsine Technologies, Inc.
Cardiovascular · 87d
Cleared Feb 14, 2003
GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
K024071 · NHW
Guidant Corporation, Cardiac Surgery
Cardiovascular · 66d
Cleared Feb 12, 2003
A16 BLOOD FLOW MEASUREMENT SYSTEM
K023707 · JOM
D. E. Hokanson, Inc.
Cardiovascular · 100d
Cleared Feb 12, 2003
WELCH ALLYN VITAL SIGN MONITOR WITH MP506
K024005 · DXN
Welch Allyn, Inc.
Cardiovascular · 70d
Cleared Feb 11, 2003
MEDSTAR SYSTEM, MODELS 533-300
K020534 · DXH
Cybernet Medical
Cardiovascular · 357d
Cleared Feb 11, 2003
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K030313 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 12d
Cleared Feb 10, 2003
VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER,...
K023800 · JOW
Aircast, Inc.
Cardiovascular · 88d
Cleared Feb 10, 2003
ALLON 2001 VERSION 5
K024128 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 56d
Cleared Feb 05, 2003
REPROCESSED COMPRESSION SLEEVE
K021654 · JOW
Alliance Medical, Inc.
Cardiovascular · 261d
Cleared Feb 03, 2003
RADIUS MICRO SNARE
K022201 · MMX
Radius Medical Technologies, Inc.
Cardiovascular · 213d
Cleared Feb 03, 2003
ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066
K024118 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 49d
Cleared Jan 31, 2003
BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)
K022596 · DQK
Clover Hi-Tech, Inc.
Cardiovascular · 179d
Cleared Jan 31, 2003
PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB
K024053 · DTB
Oscor, Inc.
Cardiovascular · 53d
Cleared Jan 30, 2003
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
K021340 · DRN
External Counterpulsation Lab
Cardiovascular · 279d
Cleared Jan 30, 2003
ANGIONEW-IV
K023701 · DRN
Living Data Technologies Corporation
Cardiovascular · 87d
Cleared Jan 29, 2003
CARDIMA ABLATION SYSTEM
K022008 · OCL
Cardima, Inc.
Cardiovascular · 224d
Cleared Jan 27, 2003
ACIST GENTOO CONTRAST INJECTION SYSTEM
K020892 · DXT
Acist Medical Systems
Cardiovascular · 314d
Cleared Jan 27, 2003
ERA 3000
K022360 · DTA
Biotronik, Inc.
Cardiovascular · 192d
Cleared Jan 27, 2003
PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED,...
K022929 · MKJ
Cardiac Science, Inc.
Cardiovascular · 145d
Cleared Jan 24, 2003
FLOWLINE BIOPORE EPTFE VASCULAR GRAFT
K021547 · DSY
Jotec GmbH
Cardiovascular · 259d