21 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COLUMBUS (PS)
FDA 510(k)
FDA Class 2
·Orthopedic
TriVerse Femoral Component CR
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215100162·
SECURMIX
FDA 510(k)
FDA Class 2
·General Hospital
ORION PLATINUM
FDA 510(k)
FDA Class 2
·Neurology
ZEPHIR® ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·April 24, 2014
UNK-RAILWAY
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code DRE·August 5, 2020
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 18, 2011
ERBE
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·November 2, 2022
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·January 3, 2017
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·September 20, 2013
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·April 2, 2013
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Malfunction
·COOK INC·Product code MIH·March 21, 2011
BIPOL LEAD MODEL
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·April 16, 2008
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·October 12, 2011
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
UNK-RAILWAY
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code DRE·August 7, 2020
ERBE
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·March 8, 2023
ERBE
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code GEI·February 18, 2025
ERBE
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code GEI·July 27, 2022
FEM IM NAIL 14MMDX30CM LEFT, FEM IM NAIL 14MMDX30CM RIGHT FEM IM NAIL 13MMDX32CM LEFT FEM IM NAIL 14MMDX32CM LEFT FEM IM NAIL 13MMDX32CM RIGHT FEM IM NAIL 14MMDX32CM RIGHT FEM IM NAIL 11MMDX34CM LEFT FEM IM NAIL 13MMDX34CM LEFT FEM IM NAIL 14MMDX34CM LEFT FEM IM NAIL 11MMDX34CM RIGHT FEM IM NAIL 13MMDX34CM RIGHT FEM IM NAIL 14MMDX34CM RIGHT FEM IM NAIL 11MMDX36CM LEFT FEM IM NAIL 12MMDX36CM LEFT FEM IM NAIL 13MMDX36CM LEFT FEM IM NAIL 14MMDX36CM LEFT FEM IM NAIL 11MMDX36CM RIGHT FEM IM NAIL 12MMDX36CM RIGHT FEM IM NAIL 13MMDX36CM RIGHT FEM IM NAIL 14MMDX36CM RIGHT FEM IM NAIL 10MMDX38CM LEFT FEM IM NAIL 11MMDX38CM LEFT FEM IM NAIL 12MMDX38CM LEFT FEM IM NAIL 13MMDX38CM LEFT FEM IM NAIL 14MMDX38CM LEFT FEM IM NAIL 10MMDX38CM RIGHT FEM IM NAIL 11MMDX38CM RIGHT FEM IM NAIL 12MMDX38CM RIGHT FEM IM NAIL 13MMDX38CM RIGHT FEM IM NAIL 14MMDX38CM RIGHT FEM IM NAIL 10MMDX40CM LEFT FEM IM NAIL 11MMDX40CM LEFT FEM IM NAIL 12MMDX40CM LEFT FEM IM NAIL 13MMDX40CM LEFT FEM IM NAIL 14MMDX40CM LEFT FEM IM NAIL 10MMDX40CM RIGHT FEM IM NAIL 11MMDX40CM RIGHT FEM IM NAIL 12MMDX40CM RIGHT FEM IM NAIL 13MMDX40CM RIGHT FEM IM NAIL 14MMDX40CM RIGHT FEM IM NAIL 10MMDX42CM LEFT FEM IM NAIL 11MMDX42CM LEFT FEM IM NAIL 12MMDX42CM LEFT FEM IM NAIL 13MMDX42CM LEFT FEM IM NAIL 14MMDX42CM LEFT FEM IM NAIL 10MMDX42CM RIGHT FEM IM NAIL 11MMDX42CM RIGHT FEM IM NAIL 12MMDX42CM RIGHT FEM IM NAIL 13MMDX42CM RIGHT FEM IM NAIL 14MMDX42CM RIGHT FEM IM NAIL 10MMDX44CM LEFT FEM IM NAIL 11MMDX44CM LEFT FEM IM NAIL 12MMDX44CM LEFT FEM IM NAIL 13MMDX44CM LEFT FEM IM NAIL 14MMDX44CM LEFT FEM IM NAIL 10MMDX44CM RIGHT FEM IM NAIL 11MMDX44CM RIGHT FEM IM NAIL 12MMDX44CM RIGHT FEM IM NAIL 13MMDX44CM RIGHT FEM IM NAIL 14MMDX44CM RIGHT FEM IM NAIL 10MMDX46CM LEFT FEM IM NAIL 11MMDX46CM LEFT FEM IM NAIL 12MMDX46CM LEFT FEM IM NAIL 13MMDX46CM LEFT FEM IM NAIL 14MMDX46CM LEFT FEM IM NAIL 10MMDX46CM RIGHT FEM IM NAIL 11MMDX46CM RIGHT FEM IM NAIL 12MMDX46CM RIGHT FEM IM NAIL 13MMDX46CM RIGHT FEM IM NAIL 14MMDX46CM RIGHT FEM IM NAIL 10MMDX48CM LEFT FEM IM NAIL 11MMDX48CM LEFT FEM IM NAIL 12MMDX48CM LEFT FEM IM NAIL 13MMDX48CM LEFT FEM IM NAIL 10MMDX48CM RIGHT FEM IM NAIL 11MMDX48CM RIGHT FEM IM NAIL 12MMDX48CM RIGHT FEM IM NAIL 13MMDX48CM RIGHT FEM IM NAIL 10MMDX50CM LEFT FEM IM NAIL 11MMDX50CM LEFT FEM IM NAIL 12MMDX50CM LEFT FEM IM NAIL 13MMDX50CM LEFT FEM IM NAIL 10MMDX50CM RIGHT FEM IM NAIL 11MMDX50CM RIGHT FEM IM NAIL 12MMDX50CM RIGHT FEM IM NAIL 13MMDX50CM RIGHT
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017