BEUDAMED
    11 results · 25ms · Sources: EU EUDAMED, US FDA

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    GOLD CIRCLE COIN

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    n/a

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902411328·INSTRUMENT 2900357 16MM SHAVER

    AQUALOC®

    FDA UDI
    Biomet Orthopedics, LLC·00880304401051·

    CLEO INFUSION SET

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·March 12, 2021

    HYDROFRAME (HES)

    FDA 510(k)
    FDA Class 2 ·Neurology

    EZ CONNECT RESIN

    FDA 510(k)
    FDA Class 2 ·Dental

    SROM*STM ST,30+4L NK,16X11X150

    FDA Adverse Event
    Injury ·DEPUY (IRELAND) 9616671·Product code JDI·June 27, 2014

    EON MINI IPG

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·October 26, 2010

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·January 7, 2013

    OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) OPHTALMIC DRAPE WITH POUCH LIF (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (10) COTTON TIP APPLICATOR 6" WOOD (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 18G X 1 Y." (1) NEEDLE HYPODERMIC 25G X 5/8" (2) EYE PAD 2 1/8 X 2 5/8 UF (5) EYE SPEAR MICRO SPONGE (2) LITE GLOVE LIF (1) CABLE BIPOLAR (1) EYE SHIELD UNIVERSAL (1) OPHTALMIC PENCIL BIPOLAR (1) IV ADM. SET 15 DROPS 106" LONG L/F (1) TABLE COVER REINFORCED 50" X 90" UF (1) KNIFE/BLADE MIN. EDGE ROUND (1) KNIFE 15 5.0 CONTROLLED (1) PLASTIC TRAY 3/COMPARTMENT (1)KNIFE 3.2MM ANGLE BEVEL UP (1) CYSTOTOMO IRRIG. 25GA X5/8 (1) MAYO TRAY LARGE (2) GOWN STANDARD LARGE SMS STD VELCRO NECK (1) PVP PAINT 8" STICK SPONGE (1) NEEDLE & BLADE COUNTER 30c MAG/MAG/LF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    Zeiss brand IOLMaster, Version 1-5, 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