11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ETEST VORICONAZOLE 0.002-32 UG/ML
FDA 510(k)
FDA Class 2
·Microbiology
EUPALAMUS DEFLECTABLE STYLET, MODEL 01545
FDA 510(k)
FDA Class 2
·Cardiovascular
HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
VERCISE CARTESIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·July 2, 2021
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Injury
·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code DQX·July 26, 2024
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 29, 2013
JELCO NEEDLE-PRO 1 ML TB TESTING SYRINGE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FMI·April 28, 2011
COBAS E411 RACK SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 23, 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