16 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BECKMAN COULTER DNASE B CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964151767·Endo Carry-on Procedure Kit contains Intercept ...
TLIF
FDA UDI
Nuvasive, Inc.·00887517062598·TLIF Inserter, 9x25mm Angled
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890106960·Zirlux Titanium Screw compatible with: Strauman...
MACROPOREMX MANDIBULAR FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MULTI CARE THERAPEUTIC VIBRATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·March 19, 2013
OMNIFIT PLUS CEMENTED HIP STEMOBSOLETE
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·February 25, 2011
RIATA ST ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008
HISTOLOCK RESECTION DEVICE
FDA Adverse Event
Malfunction
·UNITED STATES ENDOSCOPY GROUP, INC.·Product code FDI·May 27, 2021
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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
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