12 results
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23ms
·
Sources: EU EUDAMED, US FDA
NON-CONDUCTIVE ANESTHESIA FACE MASK
FDA 510(k)
FDA Class 1
·Anesthesiology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114117·SIMCOE CORTEX EXTR 23GA 0.4MM TXT PK/10
CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1
FDA 510(k)
FDA Class 2
·General Hospital
FS ACTIVATOR III
FDA 510(k)
FDA Unclassified
·Unknown
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·May 9, 2014
LARGE SUTURECUT NEEDLEDRIVE
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·October 24, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·August 31, 2007
BD¿ SYRINGE WITH NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 3, 2018
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·December 5, 2024
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