18 results · 21ms · Sources: EU EUDAMED, US FDA

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CLAROX plus (Model: VX-100)

FDA 510(k)
FDA Class 2 ·Radiology

TALOS° HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B1676221417150·

TALOS° HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B1676221417000·

TALOS° HA PEEK IBF

FDA UDI
MEDITECH SPINE, LLC·B1676221417070·

UP - Vehicle - 380-55230 - 18 Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588014173·UP - Vehicle - 380-55230 - 18 Metal

AART CHIN IMPLANT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SERVO-U

FDA Adverse Event
Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·July 12, 2019

SPECTRUM IQ INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·March 23, 2022

SPECTRUM IQ INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 13, 2022

SPECTRUM IQ INFUSION PUMP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 25, 2022

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 3, 2014

LIGASURE ATLAS HANDSWITCHING 37CM

FDA Adverse Event
Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·June 28, 2013

L9000 LIGHTSOURCE

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code GCT·August 16, 2011

MENTOR MEMORYGEL BREAST IMPLANT

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FTR·April 27, 2018

SPECTRUM IQ INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 16, 2022

MENTOR MEMORYGEL BREAST IMPLANT

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FTR·April 27, 2018

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