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
8425–8448 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 24, 2002
JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA
K020515 · DWF
Jostra AG
Cardiovascular · 68d
Cleared Apr 23, 2002
WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300
K020604 · DWJ
Nellcor Puritan Bennett, Inc.
Cardiovascular · 57d
Cleared Apr 23, 2002
ANNULOFLO SYSTEM, MITRAL MODEL AR700
K021051 · KRH
Sulzer Carbomedics, Inc.
Cardiovascular · 22d
Cleared Apr 22, 2002
HOMMED CENTRAL STATION
K020184 · DXN
Hommed, LLC
Cardiovascular · 94d
Cleared Apr 19, 2002
MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
K021213 · MAL
Boston Scientific Corp
Cardiovascular · 2d
Cleared Apr 17, 2002
KSEA FIBERSCOPE
K011793 · LYK
KARL STORZ Endoscopy-America, Inc.
Cardiovascular · 313d
Cleared Apr 17, 2002
EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
K020864 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Apr 17, 2002
SPYGLASS 4 FR ANGIOGRAPHICY CATHETER
K020890 · DQO
St Jude Medical
Cardiovascular · 29d
Cleared Apr 12, 2002
LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE
K011903 · DQK
Vivometrics, Inc.
Cardiovascular · 298d
Cleared Apr 12, 2002
HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP
K012650 · JOW
Hygia Health Services, Inc.
Cardiovascular · 242d
Cleared Apr 12, 2002
HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200
K012651 · JOW
Hygia Health Services, Inc.
Cardiovascular · 242d
Cleared Apr 12, 2002
HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10,...
K012654 · JOW
Hygia Health Services, Inc.
Cardiovascular · 242d
Cleared Apr 12, 2002
HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP
K012657 · JOW
Hygia Health Services, Inc.
Cardiovascular · 242d
Cleared Apr 12, 2002
ABP-2000 G-3
K021029 · DXN
Biotrac, Inc.
Cardiovascular · 14d
Cleared Apr 11, 2002
AXILLARY ACCESS ARTERIAL CANNULA
K002578 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 601d
Cleared Apr 11, 2002
ZOLL PAD WITH CPR AID
K011541 · MKJ
Zoll Medical Corp
Cardiovascular · 328d
Cleared Apr 11, 2002
HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB
K012956 · JOW
Hygia Health Services, Inc.
Cardiovascular · 219d
Cleared Apr 11, 2002
MODIFICATION TO FOX PTA CATHETER
K020854 · LIT
Jomed AG
Cardiovascular · 27d
Cleared Apr 10, 2002
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER
K020106 · DTR
Gish Biomedical, Inc.
Cardiovascular · 89d
Cleared Apr 09, 2002
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP
K010281 · DTB
Biotronik, Inc.
Cardiovascular · 434d
Cleared Apr 09, 2002
CARDIOVENTION CORX SYSTEM, MODEL FG 0001
K012325 · KFM
Cardiovention, Inc.
Cardiovascular · 260d
Cleared Apr 09, 2002
ASTRONOMER PLUS SYSTEM
K013349 · DQK
Ep Technologies, Inc.
Cardiovascular · 182d
Cleared Apr 08, 2002
MONITORING SYSTEM,MODEL ARGUS PB-1000
K012226 · MHX
Schiller AG
Cardiovascular · 266d
Cleared Apr 08, 2002
HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330,...
K012417 · JOW
Hygia Health Services, Inc.
Cardiovascular · 252d