7 results
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32ms
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Sources: EU EUDAMED, US FDA
STERILAB, INC.
FDA registration
STERILAB, INC.·2 products·🇺🇸 United States
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
FDA Enforcement
Class II
·Terminated·Ortho Solutions Inc·October 14, 2015
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
FDA Recall
Terminated
·Ortho Solutions Inc 330 Franklin Tnpk·Product code HWC·July 14, 2015
Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
FDA Recall
Terminated
·Aesculap, Inc.·Product code LRZ·November 10, 2015
Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesculap AG: These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
FDA Recall
Terminated
·Aesculap, Inc.·Product code LRZ·November 10, 2015
Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
FDA Recall
Terminated
·Aesculap, Inc.·Product code LRZ·November 10, 2015
Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector, Sterile; c. Part number 57-401, Female Lock - Male Lock Guarded Luer Connector, Sterile; d. Part number 57-402, Female Slip - Female Lock Guarded Luer Connector, Sterile; and e. Part number 57-403, Female Slip - Female Slip Guarded Luer Connector.
FDA Recall
Open, Classified
·International Medical Industries, Inc.·Product code LHI·September 16, 2022