BEUDAMED
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    IROOT FM

    FDA 510(k)
    FDA Class 2 ·Dental

    Eagle Heavy Duty Latex Examination Gloves

    FDA UDI
    Eagle Protect Pbc·09421024254865·Heavy Duty Latex Examination Gloves, Blue, Powd...

    ArgenZ HT+ 98x14 ML A1B

    FDA UDI
    ARGEN CORPORATION, THE·D818130312·Dental porcelain/ceramic restoration kit

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925013605·SCHEER REGULAR RIGHT ANGLE PICK

    NUPRO®

    FDA UDI
    Dentsply Professional·D0031303121·NUPRO® 5% Sodium Fluoride White Varnish, Patien...

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1303120·

    osmium™, ADDplus™

    FDA UDI
    Ulrich GmbH & Co. KG·04052536090570·osmium screw incl. bolt grey, Ø 4.0 mm, length...

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973101154·Poly Insert PS, Size 3, 12mm

    Scorpio

    FDA UDI
    Howmedica Osteonics Corp.·07613154005796·Posterior Stabilized Tibial Insert

    ADDplus

    FDA UDI
    Ulrich GmbH & Co. KG·04052536212712·osmium screw incl. bolt grey, Ø 4.0 mm, length ...

    PORTA IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GALAXY G3 MINI 1MM X 3CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·May 21, 2020

    NON-HEATED ADULT BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZO·September 5, 2013

    SERIES 20000 LEGACY

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 22, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    DANYANG HUAYI MEDICAL SUPPLY&EQUIPMENT CO.,LTD·Product code IOR·September 30, 2014

    ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code FGE·June 16, 2011

    VASO VIEW HEMOPRO

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 15, 2019

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022