10 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable
FDA 510(k)
FDA Class 2
·Cardiovascular
Sacroiliac (SI) Belt
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357633067·
Sacroiliac Belt
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357000142·
Sacroiliac Belt
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00080235700142·
ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72
FDA 510(k)
FDA Class 2
·Hematology
CARDIO 7
FDA 510(k)
FDA Class 2
·Cardiovascular
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 11, 2013
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 15, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·September 9, 2008
Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-quantitative in vitro susceptibility testing
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024