10 results
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20ms
·
Sources: EU EUDAMED, US FDA
FLUID-FILLED TEETHER
FDA 510(k)
FDA Class 2
·Dental
THE BIOPLATE MANDIBLE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
HOLY DRAGON ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 2, 2019
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 3, 2013
SUREFLEX FIBERS
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·September 16, 2014
MASK, NON-REBREATH W/ SAFETY VENT, PEDIATRIC
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code KGB·April 11, 2011
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 27, 2020
PENTAX
FDA Adverse Event
Injury
·HOYA CORP.·Product code FDT·July 24, 2015
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