11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SIGN HIP CONSTRUCT (SHC), MODEL: 701
FDA 510(k)
FDA Class 2
·Orthopedic
MAYBE?MOM MINI OVULATION MICROSCOPE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01
FDA 510(k)
FDA Class 2
·General Hospital
LINEAR? 3-4
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 24, 2025
AVIATOR ASSY TWO LEVEL PLATE SIZE 28
FDA Adverse Event
Injury
·STRYKER SPINE-FRANCE·Product code KWQ·October 17, 2016
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 28, 2022
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·April 29, 2013
VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code MZO·May 10, 2011
MERCI RETRIEVAL SYSTEM
FDA Adverse Event
Death
·CONTENTRIC MEDICAL·Product code NRY·July 30, 2008
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