BEUDAMED
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    DENTAL CAVITY VARNISH, CONCENTRATED

    FDA 510(k)
    FDA Class 2 ·Dental

    MGB Alert® Bordetella P/PP Probe Mix ASR - 48 Reactions

    FDA UDI
    Elitechgroup Mdx LLC·03661540951886·"MGB Alert® B. pertussis / B. parapertussis Pro...

    DENTAL UNIT WITH CHAIR

    FDA 510(k)
    FDA Class 1 ·Dental

    MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD PYXIS¿ MEDSTATION¿ ES

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·May 9, 2026

    UNSPECIFIED BY THE COMPLAINANT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code PAG·April 3, 2014

    NAIL

    FDA Adverse Event
    Injury ·Product code HSB·October 17, 2012

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 16, 2016

    BD PYXIS¿ MEDSTATION¿ ES

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·August 19, 2025

    Precept Medical Products, Foam Fog Shield Surgical Mask Green Fiberglass Free, REORDER #: 65-3320, non-sterile, 25/box, 6 box/case, Precept Medical Products, Inc., Arden, NC 28704, 1-800-438-5827, Mexico

    FDA Recall
    Terminated ·Precept Medical Products, Inc.·Product code FYA·September 14, 2007

    Precept Medical Products, Tape Fog Shield Surgical Mask Green Fiberglass Free, REORDER #: 65-3322, non-sterile, 50/box, 5 box/case, Precept Medical Products, Inc., Arden, NC 28704, 1-800-438-5827, Mexico

    FDA Recall
    Terminated ·Precept Medical Products, Inc.·Product code FYA·September 14, 2007

    TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code JPA·June 20, 2013

    Pulmonary Hemi-Artery SG Used in heart surgery

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code DXZ·November 22, 2013

    BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid arteries).

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code MUQ·June 4, 2018

    TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022 a multipurpose system for in vitro coagulation studies

    FDA Recall
    Terminated ·Haemoscope Division of Haemonetics Corp·Product code JPA·January 28, 2011

    Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.

    FDA Recall
    Terminated ·Haemonetics Corporation·Product code JPA·January 26, 2015

    CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the patch into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long-term storage at or below 135 C. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk and pulmonary branch.

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code DXZ·November 10, 2020

    CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a liquid nitrogen freezer for long-term storage at or below 135C. CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code OHA·November 10, 2020

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021