9 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F
FDA 510(k)
FDA Class 2
·Cardiovascular
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496053491·TOP, SIZE S, CHAMPAGNE, MICRO-MASSAGING TOP WIT...
AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DREAMSTATION AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 21, 2022
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·April 11, 2013
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 28, 2008
CAPSURE SP NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 13, 2011
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012