BEUDAMED
    9 results · 10ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·June 14, 2017

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

    Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neurosurgery·July 26, 2023

    OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique, 010-107-1209/Small 7 Degree 12mm X 9mm, 010-107-1411/Small 7 Degree 14mm X 11mm, 010-107-1613/Small 7 Degree 16mm X 13mm, 010-113-1006/Small, 13 Degree 10mm X 6mm, 010-113-1006-2/Small, 13 Degree, 10mm X 6mm - Oblique, 010-113-1208/Small 13 Degree 12mm X 8mm, 010-113-1410/Small 13 Degree 14mm X 10mm, 010-113-1612/Small 13 Degree 16mm X 12mm, 010-119-1407/19 Degree 14mm X 7mm, 010-119-1609/Small 19 Degree 16mm X 9mm, 010-119-1811/Small 19 Degree 18mm X 11mm, 010-125-1606/Small 25 Degree 16mm X 6mm, 010-125-1808/Small 25 Degree 18mm X 8mm, 010-207-1007/Medium 7 Degree 10mm X 7mm, 010-207-1007-2/Medium 7 Degree 10mm X 7mm - Oblique, 010-207-1209/Medium 7 Degree 12mm X 9mm, 010-207-1411/Medium 7 Degree 14mm X 11mm, 010-207-1613/Medium 7 Degree 16mm X 13mm, 010-213-1206/Medium 13 Degree 12mm X 6mm, 010-213-1408/Medium 13 Degree 14mm X 8mm, 010-213-1610/Medium 13 Degree 16mm X 10mm, 010-213-1812/Medium 13 Degree 18mm X 12mm, 010-219-1406/Medium 19 Degree 14mm X 6mm, 010-219-1608/Medium 19 Degree 16mm X 8mm, 010-219-1810/Medium 19 Degree 18mm X 10mm, 010-225-1807/Medium 25 Degree 18mm X 7mm, 010-225-2009/Medium 25 Degree 20mm X 9mm, 010-307-1006/Large 7 Degree,10mm X 6mm, 010-307-1006-2/Large 7 Degree 10mm X 6mm - Oblique, 010-307-1208/ Large 7 Degree 12mm X 8mm, 010-307-1410/Large 7 Degree 14mm X 10mm, 010-307-1612/Large 7 Degree 16mm X 12mm, 010-313-1205/Large 13 Degree 12mm X 5mm, 010-313-1407/Large 13 Degree 14mm X 7mm, 010-313-1609/Large 13 Degree 16mm X 9mm, 010-313-1811/Large 13 Degree 18mm X 11mm, 010-313-2013/Large 13 Degree 20mm X 13mm, 010-319-1606/Large 19 Degree 16mm X 6mm, 010-319-1808/ Large 19 Degree 18mm X 8mm, 010-319-2010/ Large 19 Degree 20mm X 10mm, 010-325-2007/Large 25 Degree 20mm X 7mm, 010-325-2209/ Large 25 Degree 22mm X 9mm, Implant Kits containing OneLIF Interbody Cages, Name/Kit Family: Kit-OneLIF-10 mm (716)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (717)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (718)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (719)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (722)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (723)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (724)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (733)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (734)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (737)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (738)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (746)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (751)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (761)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (762)/Kit-OneLIF-10 mm, Kit-OneLIF-10 mm (787)/Kit-OneLIF-10 mm, Kit-OneLIF- IMPOneLIF Implant Kit (701)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (702)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (703) NL/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (704)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (705)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (706)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (708)/Kit-OneLIF-IMP - OneLIF Implant Kit, Kit-OneLIF-IMP - OneLIF Implant Kit (709)/Kit-OneLIF-IMP - OneLIF Implant Kit,

    FDA Enforcement
    Class II ·Ongoing·Novapproach Spine, LLC·May 27, 2026

    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Hemodialysis Delivery System, Software Version 2.x.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 2021

    Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015