BEUDAMED
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    CONTINUOUS VOLUME VENTILATOR MODEL LP10

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    APK

    FDA UDI
    APK Technology Co.,Ltd.·06946725536230·Nellcor Compatible Reusable Adult Ear Clip SpO2...

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113592·PERIBULBAR NEEDLE 25GA 16MM

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06945664829458·Reusable SpO2 Sensor/Nellcor/Ear clip/Adult/1.1...

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024202061·

    MACH LED MC

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

    SPIRIT ACUPUNCTURE NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Zimmer® Foot and Ankle System

    FDA UDI
    Zimmer, Inc.·00889024076594·

    BD ECLIPSE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·November 21, 2019

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 30, 2014

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code HQL·November 11, 2010

    E360 VENTILATOR, JAPANESE EXPANDED

    FDA Adverse Event
    Injury ·NEWPORT MEDICAL INSTRUMENTS·Product code CBK·December 21, 2012

    Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·February 19, 2014

    CPS TRANSVERSE PIN 6PK 28MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·February 4, 2020

    CPS SHORT ANCHOR PLUG 20MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·February 4, 2020

    CPS XS SHT SPDL W PINS 800LBF

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·September 9, 2019

    Posterior Referencing Instrumentation for the NEXGEN COMPLETE KNEE SOLUTION PATELLA OSTEOTOMY GUIDE, REF 00-5903-010-00, NONSTERILE, Zimmer UK, Ltd.,, Zimmer Warsaw,IN This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code MBH·March 14, 2011

    3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·June 1, 2016

    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

    FDA Enforcement
    Class II ·Ongoing·Osteomed, LLC·December 15, 2021