BEUDAMED
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    CS Model+

    FDA 510(k)
    FDA Class 2 ·Dental

    Reveal

    FDA UDI
    Oticon A/S·05707131342386·G10, BTE 13 2.4G 85 C090 REVEAL

    LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)

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

    HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 23, 2025

    MIRU 1DAY UPSIDE (MIDAFILCON A)

    FDA Adverse Event
    Injury ·MENICON CO., LTD.·Product code LPL·January 22, 2025

    ANALYTICAL E MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 7, 2008

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 27, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·July 29, 2011

    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LZO·July 23, 2019

    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LZO·July 23, 2019

    OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LPH·July 23, 2019

    APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.

    FDA Recall
    Terminated ·Omnilife Science Inc.·Product code LPH·June 4, 2015

    OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LPH·September 11, 2019

    Offset Femoral Alignment Guide, 2mm x 6; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems

    FDA Recall
    Terminated ·Omnilife Science Inc.·Product code FZX·June 9, 2015

    Offset Femoral Alignment Guide 4mm x 6; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems

    FDA Recall
    Terminated ·Omnilife Science Inc.·Product code FZX·June 9, 2015

    SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-25128

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LZO·December 21, 2020

    SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LZO·December 21, 2020

    Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)

    FDA Recall
    Terminated ·Omnilife Science Inc.·Product code LZO·June 3, 2015

    SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728

    FDA Recall
    Terminated ·OMNIlife science Inc.·Product code LZO·December 21, 2020