BEUDAMED
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    NON-ELECTRIC BIOPSY FORCEPS

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950022984·SUCTION TIP FRAZIER 30 DEGREE ANGLE SIZE 11 FRE...

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746097485·DB BKT MASTER IBD UR CUSP 018 T=0 A+5 R=0

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746099229·DB BKT MASTER HGW LL 2ND BIC 018 T-22 A=0 R4D

    AEROCHAMBER MINI VENTILATION CHAMBER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CAMLOG CYLINDER IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Lenses, Soft Contact, Daily Wear

    FDA Pre-Market Approval
    FDA Class 2 ·TECHNICON-38 (POLYMACON) HYDROPHYLIC LENSES

    Lenses, Soft Contact, Daily Wear

    FDA Pre-Market Approval
    FDA Class 2 ·TECHNICON-38 POLYMACON HYDROPHILIC LENS

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·June 27, 2014

    PUMP MMT-722NAH PRDGM INS PK

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·November 8, 2010

    1.6MM WIRE GUIDE FOR 3.7MM CANNULATED LOCKING SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES ELMIRA·Product code FZX·January 7, 2013

    Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 10, 2019

    Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·November 7, 2018

    UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·October 1, 2014

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021