8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FORA G71A BLOOD GLUCOSE MONITORING SYSTEM, TD-4274 BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MODIFICATION TO MALE TO MALE LUER ADAPTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENTERYX INJECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 6, 2013
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code FSA·September 16, 2014
RSP SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·April 21, 2011
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013
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