9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA
FDA 510(k)
FDA Class 2
·Immunology
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5820307020·SCISSORS, SURGICAL TISSUE, DENTAL
XUB EXTERNAL ULTRASOUND
FDA 510(k)
FDA Class 2
·Physical Medicine
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PLUM LS PRIM. 225 CM CLAVE PORT DISTA
FDA Adverse Event
Injury
·HOSPIRA COSTA RICA LTD.·Product code FPA·March 22, 2013
SPECTRANETICS LEAD LOCKING DEVICE
FDA Adverse Event
Death
·SPECTRANETICS CORPORATION·Product code DRB·April 2, 2013
ACCU-CHEK FLEXLINK PLUS
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·March 22, 2011
STERLING OVER-THE-WIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQY·April 15, 2008
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