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