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

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    MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated Body Temperature Screening module, for use as a medical diagnostic purposes as part of a telethermographic system utilizing FLIR cameras, Models A615sc and A315sc. Cameras are private labeled as MAX Basic, MAX 76 and MAX 307.

    FDA Enforcement
    Class II ·Terminated·Med-Hot Thermal Imaging, Inc.·May 17, 2017

    ECT Internal Fracture Fixation Quick-Connect Drill 4.0 mm Diameter 20cm Length, Item Number/EDI 00241004000, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Quick-Connect Drill 3.5 mm Diameter 11 cm Length, Item Number/EDI 00241003500, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804500, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length, Item Number/EDI 00241001500, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill Bits 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804506, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Long Drill, 6.4 mm (1/4 Inch) Diameter 20.3 cm(8 Inch) Length, Item Number/EDI 00129100406, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 12.5 cm Length, Item Number/EDI 00241002100, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 10 cm Length, Item Number/EDI 00241002000, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 12.5 cm Length, Item Number/EDI 00241002600, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 11 cm Length, Item Number/EDI 00241002500, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill Bits 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803506, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803500, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch), Item Number/EDI 00231801100, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Quick-Connect Drill 2.7 mm Diameter 10 cm Length, Item Number/EDI 00241002700, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231801106, Nonsterile. orthopedic surgical instrument.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code HWE·May 22, 2017

    ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231801106, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802700, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803200, Nonsterile. orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·October 4, 2017

    ECT Internal Fracture Fixation Drill 2.0 mm Diameter (.079 Inch), Item Number/EDI 00231802000, Nonsterile. orthopedic surgical instrument.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code HWE·May 22, 2017