10 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CALTRIX RESORBABLE BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
MOSFET AUTOSENSE, MODEL TN-RD-60
FDA 510(k)
FDA Class 2
·Radiology
GLUCOLEADER VALUE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SURETEK
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code MHY·March 5, 2021
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 29, 2013
ATS CRYOMAZE 10-S PROBE
FDA Adverse Event
Malfunction
·ATS MEDICAL·Product code OCL·April 27, 2011
ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·July 25, 2008
Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
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