BEUDAMED
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    THAYER SUCTION EVACUATION CONDENSATE COLLECTION

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Barricade Coil System

    FDA UDI
    BALT USA LLC·00818053020483·Barricade Coil System (BCS) is intended for the...

    EDENTA

    FDA UDI
    EDENTA ETABLISSEMENT·E312K90044710001·Dowel Pin 17 mm

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746099175·DB BRACKET MASTER SERIES MAND LEFT 1ST BICUSPID...

    ACUMED

    FDA UDI
    Acumed LLC·10806378091353·Total Wrist Fusion Plate X-Ray Template

    CONLIN MOLAR BANDS

    FDA UDI
    Ortho Arch Company Inc·D90990004717·MOLAR BAND CONLIN RX LOWER LEFT 37

    XBraid TT

    FDA UDI
    RIVERPOINT MEDICAL, LLC·00810020085334·Suture Tape

    Palladian™

    FDA UDI
    NEUROSTRUCTURES, INC·00841508106944·Cortical Screw Drill

    SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SUREFIT DUAL DISPERSIVE ELECTRODE

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

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·CLARIS(TM) REWETTING DROPS

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·WET-N-SOAK(TM) REWETTING DROPS

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·WET-N-SOAK(TM) REWETTING DROPS

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·WET-N-SOAK(TM) REWETTING DROPS

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·ER HEALTHCARE - LARGO·Product code FKX·June 27, 2014

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·January 7, 2013

    P4 28MM 10DEG INSERT OSTEOLOCK

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code LPH·November 9, 2010

    Wallach LL100 Cryosurgical Freezer No Connector CO2 System Model: 900047.

    FDA Recall
    Terminated ·Cooper Surgical, Inc.·Product code GEH·September 29, 2009

    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