12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405)
FDA 510(k)
FDA Class 2
·General Hospital
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
ALOKA UST-5280-5
FDA 510(k)
FDA Class 2
·Radiology
INSORB
FDA Adverse Event
Other
·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008
INSORB
FDA Adverse Event
Other
·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008
INSORB
FDA Adverse Event
Other
·INCISIVE SURGICAL, INC.·Product code GAG·January 18, 2008
DEPUY PINNACLE ACETABULAR CUP SZ MM 50
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·April 11, 2013
ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code BTR·August 20, 2014
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·April 19, 2011
THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·April 7, 2026
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018