15 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RICHARDS TOTAL/PARTIAL PROSTHESIS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYNTHES LCP DISTAL FEMUR PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·February 28, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·October 26, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·August 22, 2022
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·November 28, 2023
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·April 18, 2023
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·September 25, 2024
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·October 15, 2025
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·October 1, 2024
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 14, 2013
MOOG CURLIN MEDICAL PAIN SMART IOD
FDA Adverse Event
Injury
·MOOG MEDICAL DEVICES GROUP·Product code FRN·January 11, 2011
DUROM ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·July 14, 2014
R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017