BEUDAMED
    145 results · 7ms · Sources: EU EUDAMED, US FDA

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    DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means

    FDA Enforcement
    Class II ·Terminated·DRG Instruments GmbH·August 14, 2019

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·July 28, 2021

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·July 28, 2021

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·July 28, 2021

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Novation GXL Liner, 10 Deg Face, 28mm. Orthopedic hip implant component.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·July 28, 2021

    MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 24, 2020

    TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric fractures as well as proximal femoral osteotomies

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·July 27, 2016

    Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·April 19, 2023

    ZIMTRON 6 DEG 22 HEADS

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·February 26, 2014

    90 DEG RIGHT ANGLE ATTACH, BLACK MAX

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

    23.5 Deg Rasp Handle Assy- LEFT Nonsterile

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 20, 2014

    23.5 Deg Rasp Handle Assy- RIGHT Nonsterile

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 20, 2014

    Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·October 20, 2021

    Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 30, 2017

    Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·August 30, 2017

    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840

    FDA Enforcement
    Class II ·Terminated·OMNIlife science Inc.·September 11, 2019

    Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·June 19, 2024

    Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·June 19, 2024

    Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·June 19, 2024

    Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·June 19, 2024