BEUDAMED
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    The iNAP One Sleep Therapy System

    FDA 510(k)
    FDA Class 2 ·Dental

    Zavation

    FDA UDI
    Zavation LLC·00842166133075·Ti3Z CIF 14mmx16mmx7mm -9 deg

    ZAVATION

    FDA UDI
    Zavation LLC·00842166105164·CIF 14x16, 9 deg, -07

    ZEUS-P

    FDA UDI
    SPINAL ELEMENTS·00840916122942·Zeus-P Implant 7 x 9 x 22mm

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167522209070·

    ZEUS-P

    FDA UDI
    SPINAL ELEMENTS·00840916153458·Zeus PLIF, Curved Cage 22mm x 09mm x 07mm

    Inspire Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C33422090701·Porous PEEK PLIF Spacer, 22 x 9 x 7mm, 0 deg

    NEUROLINE, SUBDERMAL NEEDLE ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ZOLL R SERIES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    BD® BLUNT FILL NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·July 11, 2023

    ECHO FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 25, 2018

    ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·November 3, 2014

    PHILIPS / ACHIEVA 1.5

    FDA Adverse Event
    Injury ·Product code LNH·October 31, 2008

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 11, 2013

    BD MAX¿ ENTERIC VIRAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·February 23, 2024

    AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Cayenne Medical Inc.·August 1, 2018