11 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NOBELREPLACE CC PMC RP 4.3X10MM
FDA Adverse Event
Injury
·NOBEL BIOCARE USA INC·Product code DZE·June 15, 2021
NOBELPARALLEL CC NP 3.75X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·March 8, 2021
NOBELPARALLEL CC NP 3.75X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·March 8, 2021
NOBELREPLACE HEXAGONAL IMPLANT
FDA 510(k)
FDA Class 2
·Dental
DIASUS
FDA 510(k)
FDA Class 2
·Radiology
MICROMANIPULATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EXPEDIUM SINGLE-INNER SETSCREW
FDA Adverse Event
Malfunction
·DEPUY SYNTHES SPINE·Product code NKB·April 23, 2013
REALIZE ADJ GASTRIC BAND STR
FDA Adverse Event
Injury
·OBTECH MEDICAL SARL_·Product code LTI·April 29, 2011
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MAV·July 31, 2010
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