4 results
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35ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
FDA Enforcement
Class II
·Terminated·Remington Medical Inc.·October 17, 2012
Arthrocare 3mm ParaFix Anchor, single strand of Magnum Wire,Part Number: 22-5010, Axya Medical, Inc., Beverly, MA 01915
FDA Recall
Terminated
·Axya Medical·Product code MBI·September 27, 2007
Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF # or Catalog Number: S313141. (systems affected by this action include M2a-Magnum, Regenerex, Acetabular Revision Shell and M2a-38), Biomet Orthopedics, Inc., Warsaw, IN. 46581
FDA Recall
Terminated
·Biomet, Inc.·Product code LXH·September 4, 2007
Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
FDA Recall
Terminated
·Remington Medical Inc.·Product code KNW·August 29, 2012