7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REFLECTION MODIFIED ACETABULAR SHELLS
FDA 510(k)
FDA Class 2
·Orthopedic
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
FDA 510(k)
FDA Class 1
·Ophthalmic
REPROCESSED GUIDEWIRES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·March 27, 2013
KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA
FDA Adverse Event
Malfunction
·WELCH ALLYN·Product code HIB·February 16, 2011
STARCLOSE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·March 31, 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