9 results
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20ms
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Sources: EU EUDAMED, US FDA
PROSTHESIS, HIP FEMORAL COMPONENT METAL
FDA 510(k)
FDA Class 2
·Orthopedic
DETLOGIX ANNULOPLASTY RING, MODEL: 5100
FDA 510(k)
FDA Class 2
·Cardiovascular
MIS IMPLANT SYSTEM DECIVE
FDA 510(k)
FDA Class 2
·Dental
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 9, 2014
SAVVY LONG PTA DILATATION CATHETER
FDA Adverse Event
Injury
·CLEARSTREAM TECHNOLOGIES LTD·Product code LIT·October 24, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 10, 2007
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
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024