11 results · 27ms · Sources: EU EUDAMED, US FDA

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DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA®

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·August 28, 2018

BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES

FDA 510(k)
FDA Class 2 ·Dental

ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES)

FDA 510(k)
FDA Class 2 ·Ophthalmic

STRATUS CS

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 11, 2015

STRATUS CS

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 9, 2015

ADVANCE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·March 28, 2013

ACRYSOF RESTOR

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·April 14, 2011

SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

FDA Adverse Event
Malfunction ·STAAR SURGICAL·Product code HQL·June 19, 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