9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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F.A.S.T. SYSTEM SED AND CXD
FDA 510(k)
FDA Class 2
·Cardiovascular
REPROCESSED EXTERNAL FIXATION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
PURESPERM 40 AND PURESPERM 80
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AIA-1800
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code KHO·March 27, 2018
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 3, 2013
NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·May 10, 2011
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·August 1, 2008
BD ULTRA FINE¿ PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 6, 2019
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