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

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Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699588·GENUMEDI PSS BLUE, SIZE VI

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

LACTOSORB*

FDA UDI
BIOMET MICROFIXATION, INC·00841036056032·

LEONE SPA

FDA UDI
LEONE SPA·08033707014607·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 6

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197496049·RZ Rainer Ring Curettes straig...

ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II

FDA 510(k)
FDA Class 2 ·Cardiovascular

I-FUSE HAMMER TOE SYSTEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 7, 2011

VIRTUOSO DR

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LWS·June 8, 2013

POLYFLUX R CAPILLARY DIALYZER

FDA Adverse Event
Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·September 4, 2008

Allegiance Esmark 6' x 144' Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undamaged; Distributed by Cardinal Health, McGaw Park, IL 60085-8787, Made in Malaysia; Catalog 24593-064A

FDA Recall
Terminated ·International Medsurg Connection, Inc.·Product code MHW·August 16, 2006