9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLEXICARE MEDICAL ENDOTRACHEAL TUBES
FDA 510(k)
FDA Class 2
·Anesthesiology
SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·December 9, 2019
PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
FDA 510(k)
FDA Class 2
·Cardiovascular
ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWERLINK SYSTEM
FDA Adverse Event
Injury
·ENDOLOGIX, INC.·Product code MIH·April 27, 2010
GAS MODULE III RESPIRATION GAS MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code BZK·April 30, 2013
ENSEAL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GEI·August 13, 2014
*
FDA Adverse Event
Injury
·HOWMEDICA OSTEONICS CORP.·Product code KWB·May 12, 2011
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