9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70610481·Mini Sprint-Brackets 5-5 McLaugh/Benn/Trev. .02...
LIGHT BOND (QUICK CURE)
FDA 510(k)
FDA Class 2
·Dental
BSM BONE SUBSTITUTE MATERIAL
FDA 510(k)
FDA Class 2
·Orthopedic
SROM*STM ST,36+8L NK,18X13X160
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code LZO·April 16, 2013
ACRYSOF IQ TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·April 13, 2011
ACCU-CHEK AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 13, 2008
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