BEUDAMED
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    SENSILIGHT/ SENSILIGHT PLUS

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

    BABCOCK TISSUE FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896076525·BABCOCK TISSUE FORCEPS MICRO STRAIGHT TIP

    CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWQ·November 10, 2016

    CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X14MM (2X)

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWQ·September 13, 2018

    CELL-DYN EMERALD 22 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAXZERO

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·March 17, 2026

    FREESTYLE PRECISION NEO

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 10, 2017

    MECTA C VARIABLE SELF-DRILLING SCREW DIAM. 4X18MM (2X)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWQ·June 24, 2022

    CERVICAL PLATE VARIABLE SELF-TAPPING SCREW DIAM. 4X14MM (2X)

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KWQ·June 8, 2018

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC, CRMD·Product code DTS·January 13, 2014

    ALAIR BRONCHIAL THERMOPLASTY CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SAN JOSE·Product code OOY·May 31, 2013

    SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 17, 2011

    BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 21, 2023

    BD MAXZERO¿ EXTENSION SET

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 10, 2022

    CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X18MM (2X)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code KWQ·September 15, 2021

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CFN MEXICO 215 SA DE CV·Product code FPA·May 12, 2020

    BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 19, 2023

    BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 18, 2023

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015