8 results · 20ms · Sources: EU EUDAMED, 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