12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ATLANTIS ABUTMENT FOR NOBEL REPLACE INTERFACE
FDA 510(k)
FDA Class 2
·Dental
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GLYCA-DIRECT FRUCTOSAMINE
FDA 510(k)
FDA Class 2
·Hematology
TI LOW PROFILE SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 10, 2019
TI LOW PROFILE SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 10, 2019
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 11, 2013
TARGETING ARM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·March 17, 2011
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·May 23, 2008
MLRY-HD 3HOLE RLC SHL 54MM/L24
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·May 14, 2019
DELTA CER FM HD 036/-4MM 12/14
FDA Adverse Event
Injury
·.·Product code LZO·March 8, 2019
RLOC-X ARCOMXL H/W 54/36MM 24
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·March 8, 2019
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