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EBI, LLC

14 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment recall (Z-1616-2024)EBI, LLC2024-04-23
Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of recall (Z-1617-2024)EBI, LLC2024-04-23
20" Lead Wires, Replacement Part Number: 1067724-2 recall (Z-1618-2024)EBI, LLC2024-04-23
48" Lead Wires, Replacement Part Number: 1067724-4 recall (Z-1619-2024)EBI, LLC2024-04-23
Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and s recall (Z-0909-2015)Ebi, Llc2015-01-05
Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loade recall (Z-0874-2015)Ebi, Llc2014-12-24
Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal S recall (Z-1811-2014)Ebi, Llc2014-06-17
Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Sp recall (Z-0411-2014)Ebi, Llc2013-11-27
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non recall (Z-0359-2014)Ebi, Llc2013-11-19
Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral recall (Z-2292-2013)Ebi, Llc2013-09-27
Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is recall (Z-2214-2013)Ebi, Llc2013-09-17
Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris recall (Z-0954-2013)Ebi, Llc2013-03-15
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178 recall (Z-0536-2013)Ebi, Llc2012-12-17
ARRAY and POLARIS Spinal System Medium Cross Connector Non Sterile Biomet Spine, Parsippan recall (Z-0131-2011)Ebi, Llc2010-10-22

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Every clearance here is in the API, with alerts when new ones post.