14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MOUNTAINEER OCT SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DR COMFORT
FDA UDI
DJO, LLC·00888912235631·Sheer ThighHs OT W 20-30 Nude
Oticon
FDA UDI
Oticon A/S·05707131258472·H16, MINIRITE 312 WL TC
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102459·ANIS PHACO CHOPPER, RIGHT
FINE JECT INSULIN PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
ROCHE ONLINE TDM QUINIDINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·May 29, 2013
3002 SECURE II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 13, 2011
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014
EVOLUT FX VALVE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025
XVWEB
FDA Adverse Event
Injury
·PLANET DDS·Product code LLZ·March 13, 2025
SECOND OPINION
FDA Adverse Event
Injury
·PEARL INC.·Product code MYN·March 13, 2025
AMISTEM H, HA COATED STEM SIZE 6 LAT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2016
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012