10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
AUTO-MATE CAMERA
FDA 510(k)
FDA Class 2
·Radiology
HS AMICA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE
FDA 510(k)
FDA Class 1
·Dental
FOXCROSS PTA CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LIT·May 9, 2014
PUMP IN STYLE ADVANCED BREAST PUMP SHOULDER BAG
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·October 19, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 11, 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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018