BEUDAMED
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    TRIPLEPLAY PRO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517575005·CoRoent Ant TLIF Ti, 14x11x36mm 0°

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515018785·Roch-Ochs Hemo Fcps, cvd, 1x2 tth, 6 1/4"

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694046572·PrimaLIF LLIF PEEK Implant, 13mm X 26mm X 60mm,...

    BD SYRINGE 10ML LL S/C 200

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 9, 2025

    SHEAUMANN PL-980

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

    ALDAHOL III HIGH-LEVEL DISINFECTANT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BIOMET CRUCIATE TIBIAL TRAY 87MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·March 24, 2025

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    ZOOM CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 1, 2011

    ACRYSOF TORIC

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD/HUNTINGTON·Product code MJP·August 27, 2008

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 31, 2018

    Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet Spine Inc.·March 6, 2019

    Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet Spine Inc.·March 6, 2019

    Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet Spine Inc.·March 6, 2019

    BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·October 17, 2018