12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE
FDA 510(k)
FDA Class 2
·General Hospital
SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010
FDA 510(k)
FDA Class 2
·Dental
PORTADUR P 2, MODEL #2031
FDA 510(k)
FDA Class 2
·Dental
UNKNOWN COPELAND SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·April 14, 2017
COPELAND SH HUM SZ4 STND PLUS
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·June 8, 2016
UNKNOWN COPELAND HEMIARTHROPLASTY SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·October 21, 2016
UNKNOWN COPELAND RESURFACING SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·May 16, 2017
UNKNOWN COPELAND SHOULDER GLENOID COMPONENT
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·July 5, 2017
OMNILINK ELITE PERIPHERAL STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIO·April 11, 2013
CRITICATH
FDA Adverse Event
Malfunction
·BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD.·Product code DYG·May 27, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 13, 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