16 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
FDA 510(k)
FDA Class 2
·Anesthesiology
SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·April 27, 2021
MEDRELIEF
FDA 510(k)
FDA Class 2
·Neurology
COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH
FDA 510(k)
FDA Class 2
·Neurology
SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·February 22, 2021
BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·December 7, 2020
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·April 29, 2013
VITROS IMMUNODIAGNOSTICE PRODUCTS ANTI-HBS REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LOM·May 10, 2011
STERRAD 100S STERILIZER
FDA Adverse Event
Injury
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·July 29, 2008
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·January 6, 2021
SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·January 5, 2021
BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·March 19, 2021
BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE
FDA Adverse Event
Injury
·BD MEDICAL - DIABETES CARE·Product code FMF·September 16, 2020
BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·October 8, 2021
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