9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AGILTRAC .035 PERIPHERAL DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BAYER RAPIDPOINT 400 SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYMPHONY GRAFT DELIVERY SYSTEM (GDS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TSRH® SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·July 5, 2016
TSRH® SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·July 5, 2016
REPLY
FDA Adverse Event
Injury
·SORIN CRM S.R.L.·Product code NVZ·March 22, 2013
1020279-2011-00086
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS·Product code HSD·March 17, 2011
PROGRAMMING WAND
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·March 27, 2008
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