14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DATEX-OHMEDA HMEF MINI
FDA 510(k)
FDA Class 2
·Anesthesiology
BIOLOK SCREW, BIOSTEON SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MARGRON STEM (K032641)
FDA Adverse Event
Injury
·PORTLAND ORTHOPAEDICS PTY LTD·Product code KWY·May 31, 2005
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code HWC·September 23, 2015
PROFEMUR(R) Z STEM PLASMA SPRAYED
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·March 27, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Other
·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·February 14, 2011
ASCENSION PIP
FDA Adverse Event
Other
·ASCENSION ORTHOPEDICS, INC.·Product code KWF·March 31, 2008
APPLIANCE, FIXATION, NAIL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KTT·August 18, 2015
APPLIANCE,FIXATION,NAIL
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code KTT·October 10, 2016
ENDOLOOP LIGATURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GEA·December 15, 2021
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 13, 2025
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
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018