12 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ATLAS IMPLANT SYSTEM- MINI PLUS
FDA 510(k)
FDA Class 2
·Dental
Single Use Surgical Optical Fiber
FDA UDI
QUANTA SYSTEM SPA·08033945937249·Single Use Surgical Optical Fiber ø 272 µm
Dist...
PULSECO HEMODYNAMIC MONITOR CM71
FDA 510(k)
FDA Class 2
·Cardiovascular
SUNI MAX
FDA 510(k)
FDA Class 1
·Dental
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 19, 2013
IMMERSION HYDROBATH
FDA Adverse Event
Malfunction
·INVACARE CLEVELAND STREET·Product code ILJ·September 15, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 4, 2011
3.5MM TI CANCELLOUS POLYAXIAL SCREW 22MM
FDA Adverse Event
Injury
·SYNTHES PRODUKTIONS GMBH·Product code NKG·February 8, 2018
LOCKSCR SYNAPSE TAN
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKG·February 15, 2018
LOCKSCR SYNAPSE TAN
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKG·February 15, 2018
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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