7 results
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18ms
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Sources: EU EUDAMED, US FDA
BOEHRINGER LAB SUCTION INTERRUPTER
FDA 510(k)
FDA Class 2
·General Hospital
VIMPLANT
FDA 510(k)
FDA Class 2
·Radiology
Fule Metallic Lockable Intramedullary Nail Systems
FDA 510(k)
FDA Class 2
·Orthopedic
RESTORE SENSOR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 6, 2014
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 5, 2010
COMPRESSION ANASTOMOSIS RING
FDA Adverse Event
Injury
·NITI SURGICAL SOLUTIONS LTD.·Product code FZP·July 29, 2008
ULTIMA*LX STM,POL 10/12TAP/SZ5 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 11, 2012