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