BEUDAMED
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    ASCEND SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Spherodon - M

    FDA UDI
    SILMET LTD·07290012207419·Dental Amalgam Capsules

    JOBST UltraSheer

    FDA UDI
    BSN MEDICAL, INC.·00035664214937·ULTRA SHEER 30-40 MM HG KNEE HIGH CLOSED TOE EX...

    AF541

    FDA UDI
    Respironics, Inc.·00606959024496·AF541 Mask with Entrainment Elbow, Leak 1, with...

    ADVANCED GLASS IONOMER (K-130) RESTORATIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MONARCH PLATFORM

    FDA Adverse Event
    Injury ·AURIS HEALTH, INC.·Product code EOQ·September 6, 2022

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 21, 2013

    TENDRIL SDX

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

    DEXTRUS 4137

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·June 7, 2011

    95 DEG CONDYLAR PLATE 9 HOLES/80MM/156MM

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTW·March 28, 2018

    4.5MM CORTEX SCREW SELF-TAPPING 40MM

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·March 28, 2018

    Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen 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 AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 22, 2019

    Artis Q biplane, Model Number 10848282

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

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012