12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRACTION SYSTEM, DIGIT-TRAC 930
FDA 510(k)
FDA Class 2
·Physical Medicine
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776165871·Meyerding Retractor . Blds
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
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code MMH·April 11, 2013
TRANSPORT SERIES
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 16, 2011
URISYS 1800
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JIL·May 22, 2008
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
MRHK TIB INS 10MM XS/S S1/S2
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KRO·September 19, 2014
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