17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SONICATOR PLUS 940, MODEL ME940
FDA 510(k)
FDA Class 2
·Physical Medicine
RESORBABLE HAMMERTOE PIN
FDA 510(k)
FDA Class 2
·Orthopedic
AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)
FDA 510(k)
FDA Class 2
·Anesthesiology
X SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 8, 2013
REPICCI II KNEE FEMORAL COMPONENT 48MM LEFT MEDIAL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HRY·April 27, 2011
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 2008
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code QBJ·January 23, 2026
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 20, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 15, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 20, 2017
TOSOH HLC-723G8 ANALYZER
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·December 11, 2017
DAVINCI SI
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·May 4, 2020
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code LCP·January 5, 2016
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Injury
·TOSOH CORPORATION·Product code LCP·January 3, 2017
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·April 16, 2018
AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·February 18, 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