22 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WET LIGHT PERSONAL MOISTURIZER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458549·
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01308T0·Cervical Rasp, 14 x 11, 8mm, 7 Degree, Tapered
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01308N0·Cervical Rasp, 14 x 11, 8mm, 0 Degree, No Taper
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458501·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458532·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458525·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458556·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458495·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033458518·
SYNCHRON VANCOMYCIN REAGENT
FDA Adverse Event
BECKMAN COULTER INC.·Product code LEH·June 10, 2011
REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)
FDA 510(k)
FDA Class 2
·Neurology
CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008
FDA 510(k)
FDA Class 2
·Cardiovascular
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·May 13, 2022
HUDSON ADULT UNIVERSAL VENTILATOR TUBING SET
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZO·March 15, 2013
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code JDI·February 24, 2011
ACTIVA
FDA Adverse Event
Other
·MEDTRONIC·Product code MHY·March 14, 2008
ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 7, 2016
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