8 results · 19ms · Sources: EU EUDAMED, US FDA

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MODIFICATION TO SYNGO INSPACE 4D

FDA 510(k)
FDA Class 2 ·Radiology

EZ-COMFORT TRANSPORTER 2000 SERIES

FDA 510(k)
FDA Class 1 ·Physical Medicine

PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

LCS COMPLETE POST AUG 5MM MED

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS·Product code NJL·April 17, 2013

SWAN-GANZ PACEPORT PACEPORT OXIMETRY TD CATHETER WITH AMC THROMBOSHIELD

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYG·June 16, 2008

GORE DRYSEAL SHEATH

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code DYB·April 11, 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