8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V
FDA 510(k)
FDA Class 2
·Clinical Toxicology
THE 5.0 X 6.0MM DENTAL IMPLANT
FDA 510(k)
FDA Class 2
·Dental
BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 19, 2013
TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code JEY·September 5, 2014
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code MDS·April 8, 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