7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODULAR CATHCART FRACTURE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP
FDA 510(k)
FDA Class 1
·Dental
CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012
FDA 510(k)
FDA Class 2
·Cardiovascular
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 30, 2014
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·November 15, 2010
CUFFLATOR ENDO TUBE INFLATOR & MANOMETER
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code BSK·November 30, 2012
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