11 results · 19ms · Sources: EU EUDAMED, US FDA

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RULER

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

NAR

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209135172·

SOMATOMEDIN C BY RADIOIMMUNOASSAY

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SLT 220 WASHER FOR MICROITITERPLATES

FDA 510(k)
FDA Class 2 ·Microbiology

PINNACLE MTL INS NEUT40IDX56OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·November 22, 2013

CONQUEST PTA BALLOON DILATATION CATHETER

FDA Adverse Event
Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·May 27, 2014

VERSA DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NVZ·October 5, 2010

MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

FDA Adverse Event
Injury ·MEDTRONIC, INC·Product code NEK·November 27, 2012

ASPHERE M SPEC 12/14 40 +8.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 22, 2013

Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

FDA Enforcement
Class II ·Terminated·Isopure Corp·September 21, 2022

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