BEUDAMED
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    N-Doe Pillow

    FDA UDI
    N. M. BEALE COMPANY, INC.·00864390000367·

    FUSION-DOE Light System

    FDA UDI
    Dentlight Inc.·00860179001075·FUSION-DOE Light System

    COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE

    FDA 510(k)
    FDA Class 2 ·Hematology

    POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MODEL S HAND PIECE ONLY, DOES NOT INCLUDE HAND P

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES CORPORATION·Product code GEI·March 18, 2009

    MODEL S HAND PIECE ONLY, DOES NOT INCLUDE HAND P

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES CORPORATION·Product code GFD·August 12, 2013

    BLACKMAX-NEURO

    FDA Adverse Event
    Malfunction ·REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE "DOES NOT WORK". THE DEVICE·Product code HBB·September 16, 2013

    Injector, Vertebroplasty (Does Not Contain Cement)

    FDA classification
    FDA Class 1 ·Injector, Vertebroplasty (Does Not Contain Cement)

    Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.

    FDA classification
    FDA Class 2 ·Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.

    VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CGZ·September 10, 2019

    Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code DZI·March 14, 2019

    Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code DZE·March 14, 2019

    FLEXICAIR II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above the foodboard, patient scale or alternate CPR function actuators.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·August 27, 2003

    Product is Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does not include the related drill motor, foot-pedal control, motor attachments or drills/burrs)

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBC·April 23, 2003

    VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·November 13, 2019

    Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker Vision Mounting Arm can be used with any Stryker flat panel display and is It is compatible with Stryker Carts (0240099001, 0240099011 or 0240099020). It is indicated for use in a surgical operating room environment and is exposed to environmental conditions associated with the storage and shipping of the product. It is not intended to enter the sterile field. The Stryker Vision Mount does not deliver to and/or extract from the patient any energy or material. It does not process any biological materials, as it is not intended to be sterilized by the user. The Stryker Vision Mount is only used to display surgical images and video and does not sustain or support life.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code BZN·August 30, 2013

    Harris Medical UV Lamp; the device does not have a label identifying the name and place of business or manufacturer, packer or distributor. It is packaged with a "Harris UV Lamp Training Manual"

    FDA Recall
    Terminated ·Harris Medical Resources·Product code MXG·May 13, 2010

    Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·February 26, 2020

    DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED). The DDC-6-AA data card is an accessory to the AED and does not have its own intended use.

    FDA Recall
    Terminated ·Defibtech, LLC·Product code MKJ·August 27, 2010