BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    METHA HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PMMA disc

    FDA UDI
    Dentsply International Inc.·D00180719160·

    Gibson Healthcare

    FDA UDI
    BENCO DENTAL SUPPLY CO.·D74440719161·BENCO C6 3-0 PL GUT 18"/45CM

    NITINOL TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·October 6, 2017

    SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES

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

    COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX

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

    G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

    FDA Enforcement
    Class II ·Terminated·Interventional Spine Inc·January 11, 2017

    MYNX VASCULAR CLOSURE DEVICE

    FDA Adverse Event
    Malfunction ·ACCESSCLOSURE, INC.·Product code MGB·April 28, 2011

    5MM, 33CM PEEK MONOPOLAR HANDLE 33CM

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code KOG·April 22, 2013

    SPRINT

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008

    DIGTAL LIGHT SOURCE CABLE

    FDA Adverse Event
    Injury ·SHIRAKAWA OLYMPUS CO., LTD.·Product code FDF·January 30, 2025

    HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018