BEUDAMED
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    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113875·VISCO INJECTION CANNULA 30GA ANG 10MM

    RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene

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

    ISOLA

    FDA UDI
    DEPUY SPINE, LLC·10705034006819·ISOLA SPINE SYSTEM CLOSED HOOK 4.75 x 9.5mm

    Medetz Surgical Instruments

    FDA UDI
    Medetz Surgical Instruments LLC·G22392031200·Van Antrum Sinus Cannula

    Marking Pen

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113219·MARKING PEN FOR TREPHINE & PUNCH

    LINER #L FOR MOBILE LINER Ø42

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code LZO·August 30, 2023

    MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C

    FDA 510(k)
    FDA Class 2 ·Hematology

    OXYCON MOBILE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·January 13, 2016

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·July 15, 2020

    PK DISSECTING FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·October 27, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

    MAINTENANCE STATION FOR ELECTRIC PEN DRIVE

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code DZI·July 2, 2013

    COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PAO·July 20, 2017

    VERSA-DIAL SHOULDER SYSTEM COMPREHENSIVE STANDARD ADAPTOR

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBF·July 27, 2017

    COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE BASEPLATE HA

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PAO·July 20, 2017

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025