11 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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VILEX X-FIX
FDA 510(k)
FDA Class 2
·Orthopedic
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 27, 2021
LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ULTRACELL ABSORBENT STICK
FDA 510(k)
FDA Class 2
·Ophthalmic
UNKNOWN PINNACLE CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS·Product code KWA·April 11, 2013
AED
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·May 21, 2008
*
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY·Product code JWH·April 10, 2011
OXYSURE
FDA Adverse Event
Injury
·OXYSURE·Product code CAW·March 19, 2014
SEE H10
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDG·June 4, 2018
OXYSURE
FDA Adverse Event
Injury
·OXYSURE·Product code DQA·March 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