BEUDAMED
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    DIGITAL DISK RECORDER

    FDA 510(k)
    FDA Class 1 ·Radiology

    SMALL BONE BLADES

    FDA UDI
    Peter Brasseler Holdings, LLC·00887919094227·KM33-115

    Brasseler USA

    FDA UDI
    Provision·00810041064905·

    Brasseler USA

    FDA UDI
    Provision·B504OMKM331150·

    Reprocessed Oscillating/Sagittal Saw Blade, Thick, 30 x 7 x 0.51mm

    FDA UDI
    SURETEK MEDICAL·B390KM331151·

    NA

    FDA UDI
    STERILMED, INC.·10888551017077·SAW BLADE MICRO OSCILLATING 12 TEETH/CM STRYKER...

    ADAPTER NUT

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·March 15, 2011

    ORTHODEK

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·January 3, 2013

    SECHRIST DUAL HT.HYD.STRETCHER

    FDA Adverse Event
    Malfunction ·STRYKER CORP, MEDICAL DIVISION·Product code FPO·December 13, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 14, 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