9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TEMPTOUCH DERMAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
GOLDFINGER DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2024
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 1, 2021
UNKNOWN DEPUY ASR ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 26, 2013
COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, IRVINE·Product code OAD·April 14, 2011
ENDOPATH ETS-FLEX 45
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY·Product code GCJ·July 23, 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