9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TAKE ONE BITE MODIFIED
FDA 510(k)
FDA Class 2
·Dental
Microstream Luer
FDA UDI
ORIDION MEDICAL 1987 LTD.·20884521762180·Microstream Luer Watertrap
BIPAP DUET LX BI-LEVEL SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
EEI SLUSH PAN DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 19, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·March 8, 2011
AFFINITY DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2008
Oridion CO2 sampling lines and water traps under the label: Surestream CO2 Sampling Lines: SureLine Adult Part No.010976; sureLine Pediatric Part No. 010977; SureLine O2 Adult Part No.010979; SureLine O2 Pediatric Part No.010980 Smart SureLine Plus O2 Adult Part No. 010981; Smart SureLine O2 Pediatric Part No. 010982; Smart SureBloc O2 Part No. 010983; Watertrap (package of 25 units) Part No. 010994; Sure VentLine Set Adult/Pediatric Part No.010986; Sure VentLine H Set Adult/Pediatric Part No.010987; Smart SureLine Guardian O2 Part No.012533; Smart SureLine Guardian O2 Long Part No.012534;
FDA Recall
Terminated
·Oridion Medical·Product code CCK·February 16, 2012
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