9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033594·Baltic Denture System BDLoad BDLoad Mn7 PLSEbi...
BODY ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
CARRIAZO BARRAQUER SINGLE USE MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
EMERGE?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·April 3, 2013
ACCU-CHEK ® AVIVA
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code NBW·March 30, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 25, 2014
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024