BEUDAMED
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    ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SuperNova

    FDA UDI
    PURELIFE, LLC·D79010612031·SuperNova Nitrile Powder-Free, Medium, Revoluti...

    DP-REPAIR

    FDA UDI
    Denplus Inc·D8451061203·DP-REPAIR-R, RPI, 2.3 kg

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00612031·

    BioQuick®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70612031·BioQuick-Brackets FACE Evolution II System .018...

    “Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)

    FDA UDI
    Paonan Biotech Co.,Ltd.·04719878787062·Rotation Wrench

    OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOURGLASS

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code MQP·June 16, 2014

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    SHUNLONG PHYSICAL THERAPY EQUIPMENT·Product code ITJ·April 16, 2013

    3MM DOUBLE ACTION ATRAUMATIC GRASPER, 20CM

    FDA Adverse Event
    Injury ·STRYKER ENDOSCOPY SAN JOSE·Product code HRX·April 11, 2011

    CRYSTALENS

    FDA Adverse Event
    Injury ·EYEONICS, INC.·Product code HQL·June 16, 2008

    SOEHENDRA STENT RETRIEVER

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FGE·September 26, 2017

    ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·February 25, 2015

    SKBM Microkeratome cutting tool

    FDA Recall
    Terminated ·Alcon Laboratories, Inc·Product code HNO·November 18, 2002

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018