14 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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EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER
FDA 510(k)
FDA Class 2
·General Hospital
BD¿ AMBER ORAL SYRINGE WITH NON LUER TIP, 3 ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code KYW·January 20, 2023
BD¿ ORAL DISPENSING SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code KYW·October 29, 2022
XIA SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 20, 2021
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 29, 2013
LIGASURE ATLAS HANDSWITCHING 37CM
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·April 29, 2011
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 25, 2008
BD¿ ORAL DISPENSING SYRINGE 3 ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code KYW·January 4, 2022
4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code JDP·October 14, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·October 14, 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