12 results · 20ms · Sources: EU EUDAMED, US FDA

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INTERMITTENT INJECTION SITE

FDA 510(k)
FDA Class 2 ·General Hospital

1CC FUTURA SAFETY SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

Blood Collection Needle (with/without Needle Holder)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021

BARD FOLEY CATHETER WITH URIMETER

FDA Adverse Event
Malfunction ·BARD·Product code KNX·December 3, 2010

CONSERVE(R) TOTAL FEMORAL HEAD

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·January 22, 2013

TENDRIL ST

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014

HF-RESECTION ELECTRODE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023

HF-RESECTION ELECTRODE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023

HF-RESECTION ELECTRODE, LOOP, 22.5 FR., 0.35 WIRE, 12°

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code KNS·August 11, 2016

UNKNOWN

FDA Adverse Event
Injury ·OLYMPUS WINTER & IBE GMBH·Product code KNS·October 21, 2022

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