BEUDAMED
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    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772813148·GENUMEDI PRO SILVER SIZE I

    SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772813834·GENUMEDI PRO SILVER SIZE III

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772813827·GENUMEDI PRO SILVER SIZE II

    CHS

    FDA UDI
    Smith & Nephew, Inc.·03596010062734·AMBI COMPRESSION HIP SCREW SHT PLATE 4 SLOT 100...

    N/A

    FDA UDI
    TETRA MEDICAL SUPPLY CORP.·00614138016033·ALL ELASTIC SACRAL SUPPORT, DUAL ADJUST, SMALL

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867186545·JumpStart, 12" X 12", Single Layer

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383505727·Gutta Percha Points is used to root canal filin...

    CORNEAL TREPHINE BLADE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896012837·CORNEAL TREPHINE BLADE

    EPOC READER & POWER SUPPLY

    FDA Adverse Event
    Malfunction ·EPOCAL INC.·Product code CGL·October 14, 2021

    STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,

    FDA 510(k)
    FDA Class 2 ·Dental

    C7 XR IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNKNOWN PRODUCT - SET SCREW

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HWC·October 12, 2012

    ISOFLEX LEAD

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL,INC. CRMD·Product code DTB·January 13, 2014

    LOANER CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·May 20, 2013

    ARTICULEZE M HEAD 36MM +5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·June 1, 2011

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·August 12, 2016

    Artis Q biplane, Model Number 10848282

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 26, 2018

    Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 22, 2018