11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO EQUATION FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809867121·FOR MEN 20-30 MM HG THIGH MICRO DOT BAND OPEN T...
SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)
FDA 510(k)
FDA Class 2
·Neurology
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479
FDA 510(k)
FDA Class 2
·Microbiology
IPC® STYLUS TRANSNASAL BUR
FDA Adverse Event
Death
·MEDTRONIC XOMED INC.·Product code ERL·February 4, 2015
IV EVACUATED CONTAINER
FDA Adverse Event
Other
·B. BRAUN MEDICAL, INC.·Product code FPA·January 9, 2013
VS.1, TINED
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 6, 2011
UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012
UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LGD·January 13, 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