9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
IL PHENYTOIN ASSAY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Amber Mill Q Series & Amber Mill Direct Series
FDA 510(k)
FDA Class 2
·Dental
PRODESSE PROADENO
FDA 510(k)
FDA Class 2
·Microbiology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 30, 2014
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·November 7, 2010
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·November 29, 2012
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·July 1, 2020
TI MATRIXRIB PRE-CONTOURED PL 18 HOLES FOR LEFT RIBS 8 & 9
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·April 12, 2019
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