14 results · 22ms · Sources: EU EUDAMED, US FDA

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8MM TROCAR KIT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Freedom Pedicle Screw System

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215027872·

TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE

FDA 510(k)
FDA Class 2 ·Cardiovascular

PRECISION XCEED DIABETES MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 1, 2014

LIGAMAX-5MM ENDO CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 29, 2013

SECURE II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·May 12, 2011

N/A

FDA Adverse Event
Injury ·EL. EN. ELECTRONIC ENGINEERING SPA·Product code GEX·September 21, 2018

DEKA SMARTXIDE2

FDA Adverse Event
Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 22, 2021

UNKNONW

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 9, 2018

DEKA SMARTXIDE2

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·April 6, 2023

UNKNOWN

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·July 7, 2022

DEKA SMARTXIDE2

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·November 3, 2023

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