11 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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BESMED VARIOUS MODELS OF TENS, BE-550/BE-660
FDA 510(k)
FDA Class 2
·Neurology
PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
JEWEL MPS
FDA 510(k)
FDA Class 1
·Physical Medicine
UNKNOWN ORTHOSIS
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code MNI·January 6, 2017
CUB PEDIATRIC CRIB- HYD BASE
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FMS·April 2, 2013
CRYSTALENS
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code NAA·March 23, 2011
COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA
FDA Adverse Event
Malfunction
·STAAR SURGICAL COMPANY·Product code HQL·April 18, 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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018