10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPECTRANETICS VISISHEATH DILATOR SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
MODULAR PORP AND TORP MODEL TBD
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
3D HUMERAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 18, 2025
SWIFT-LOCK ANCHOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·January 23, 2018
SONOMA CRX
FDA Adverse Event
Injury
·SONOMA ORTHOPEDIC PRODUCTS INC.·Product code HSB·April 30, 2013
INFERIOR END PLATE LARGE-STERILE
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·September 16, 2014
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·May 3, 2011
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