8 results
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27ms
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Sources: EU EUDAMED, US FDA
VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208
FDA 510(k)
FDA Class 2
·Clinical Chemistry
XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
TENSCARE, MODEL TENS XL-2
FDA 510(k)
FDA Class 2
·Neurology
HUDSON NEONATAL HEATED WIRE CIRCUIT, DUAL LIMB
FDA Adverse Event
Malfunction
·TELEFLEX·Product code BZO·April 12, 2013
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 20, 2008
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·April 19, 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