16 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·January 4, 2016
NARKOMED MRI-2, MODEL NM-MRI-2
FDA 510(k)
FDA Class 2
·Anesthesiology
GAS SAMPLING LINES
FDA 510(k)
FDA Class 2
·Anesthesiology
EGIA ULTRA UNIVERSAL SHORT STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SUR·Product code GDW·April 18, 2012
ENDO GIA ROTICULATOR* 60-3.5 SULU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·October 10, 2014
IDRIVE ULTRA POWERED HANDLE 1
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·September 19, 2016
ENDO GIA* II 45-2.5 DLU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAG·October 9, 2014
ENDO GIA ROTICULATOR* 60-4.8 SULU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·November 25, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·April 29, 2013
3.5MM CORTEX SCREW SELF-TAPPING 26MM
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·September 12, 2014
DYONICS RF-S WHIRLWIND PROBE
FDA Adverse Event
Malfunction
·SMITH & NEPHEW ENDOSCOPY ANDOVER MANUFACTURE·Product code GEI·May 10, 2011
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 28, 2022
EGIA 45 ARTICULATING MED/THICK SULU
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·December 9, 2015
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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