BEUDAMED
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    E-TENG MODEL EOR 1

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564032799·D&C Pack

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523166862·Initia Acetabular Standard Liner, E-CIMA 22-56/58

    VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION

    FDA 510(k)
    FDA Class 2 ·Dental

    INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OPT SLEEVE 12X100 STABILITY

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 24, 2019

    BARD SOFT MESH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·May 17, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 26, 2014

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 14, 2011

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 31, 2019

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·November 25, 2024

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 31, 2019

    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

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020