9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
RTVUE
FDA 510(k)
FDA Class 2
·Ophthalmic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040120699·MEDIUM DOUBLE-GUIDED PALATAL EXPANSION SCREWS
SCITON IMAGE HAIR REMOVAL LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
VERSASTEP PLUS 12MM CANN/DILT W/RADEXPSL
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY USSC R·Product code GCJ·March 18, 2013
PRESSUREWIRE AERIS
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL INC.·Product code DRG·August 19, 2014
TRIDENT ACETABULAR SYSTEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code LPH·April 7, 2011
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015