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

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MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699564·GENUMEDI PSS BLUE, SIZE IV

Oxyless Blood Tubing Set

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

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699526·GENUMEDI PSS BLUE, SIZE O

CoRoent

FDA UDI
Nuvasive, Inc.·00887517566256·CoRoent Ant TLIF PEEK, 15x10x30mm 4°

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100103·BARRAQUER SPECULUM SOLID LARGE

ST AIA PACK HBA1C

FDA 510(k)
FDA Class 2 ·Hematology

FX WIRE ADVANCED MEASUREMENT GUIDEWIRE

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

COMPLETE BRAIN IMC-PROBE KIT

FDA Adverse Event
Malfunction ·GESELLSCHAFT FUR MEDIZINISCHE SONDENTECH·Product code GWM·June 23, 2004

JACKSON PRATT

FDA Adverse Event
Injury ·CARDINAL HEALTH·Product code GCD·September 10, 2015

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 7, 2014

NEW LIGASURE 5MM

FDA Adverse Event
Malfunction ·COVIDIEN LP·Product code GEI·May 30, 2013

ADJUSTABLE PIN COLLET

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·June 7, 2011

SURETRAK II UNIVERSAL TRACKER, MEDIUM CLAMP

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code OLO·September 15, 2015

ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·May 22, 2015

AIRVO2 HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 19, 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