10 results · 18ms · Sources: EU EUDAMED, US FDA

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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