9 results · 26ms · Sources: EU EUDAMED, US FDA

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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