10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FRAXEL IV SR LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DHS®/DCS® CENTERING SLEEVE LONG
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code FZX·December 8, 2016
TAKE 1
FDA 510(k)
FDA Class 2
·Dental
SLEEPBITE
FDA 510(k)
FDA Class 2
·Dental
TOTAL ASR FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·April 17, 2013
ULTRA 2 MONORAIL CUTTING BALLOON OUS
FDA Adverse Event
Malfunction
·BSC LETTERKENNY·Product code LOX·June 18, 2008
TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 15, 2011
TIP FOR DHS®/DCS® IMPACTOR (338.28)
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HWA·December 8, 2016
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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