BEUDAMED
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    MEROGEL OTOLOGIC PACK

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    RMO

    FDA UDI
    Rmo, Inc.·00885797099686·MAX MLR BDS ASST 100 SE ASIA

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001148·artVeneer life upper anteriors, IS, A4

    TruFlex

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730015211·NiTi Thermal Lower 19x25 10 archwires per pack

    TruFlex™

    FDA UDI
    Ortho Organizers, Inc.·00190707126964·TRUFLEX NiTi Thermal Lower 19x25 (10pk)

    30cm Water Phantom

    FDA UDI
    NEUROLOGICA CORP.·10815411020274·

    RGP MULTI-PURPOSE SOLUTION ID 100136

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LIGHT BOND (QUICK CURE)

    FDA 510(k)
    FDA Class 2 ·Dental

    SERIES 7000 STANDARD TIBIA

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·August 29, 2012

    NA

    FDA UDI
    Zimmer, Inc.·00889024033559·

    NA

    FDA UDI
    Zimmer, Inc.·00889024033542·

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 26, 2013

    FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33%, CELLU

    FDA Adverse Event
    Other ·PROCTER & GAMBLE MANUFACTURING CO.·Product code KOO·February 18, 2011

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·February 15, 2008

    ANATOMICAL SHOULDER SYSTEM 04.01.0001 STD HUMERAL DIAPHYSIS - CEMENTLESS - 6

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·November 10, 2022

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPT·August 7, 2025

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·April 3, 2019

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·April 3, 2019

    PROLENE HERNIA SYSTEM UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·April 3, 2019

    Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to ... a blanket that is placed over or around adult, pediatric or neonatal patients in order to warm them. The heated air is blown through a connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air. The system can be used in long-term care facilities, surgical facilities, hospitals including the Post-anesthesia Care Unit (PACU), Intensive Care Unit (ICU), Surgical Intensive Care Unit (SICU), Emergency Room (ER), Operating Room (OR), medical and surgical floors, or any other department or hospital facility requiring patient temperature management. To prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. Used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air heated blanket.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·July 20, 2011