BEUDAMED
    28 results · 19ms · Sources: EU EUDAMED, US FDA

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    VOLU-SOL EA-50 STAIN

    FDA 510(k)
    FDA Class 1 ·Hematology

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013387·Post Op Telescoping Knee Brace

    ACUMED

    FDA UDI
    Acumed LLC·10806378041181·Biotrak® Nail/Pin Cannula

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197418997·Scoville Hook, large 25x80mm

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127028878·Blade Femoral Broach Size 22

    TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200

    FDA 510(k)
    FDA Class 2 ·Immunology

    UNKNOWN SALINE IMPLANTS

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·June 24, 2020

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 8, 2014

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 9, 2012

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 27, 2015

    Nobel Biocare 17 Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore chewing function. The Multi-Unit Abutments, in combination with endosseous implants, are indicated for multiple unit reconstructions when screw retrained prosthetics are preferred.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code NHA·March 16, 2018

    4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Ser CX 311-20 120-240V 50/60Hz, item # 807QS0020CX6.

    FDA Recall
    Open, Classified ·Daavlin Distributing Company·Product code FTC·April 26, 2022

    Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code DZE·May 28, 2019

    Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4

    FDA Recall
    Open, Classified ·Daavlin Distributing Company·Product code FTC·December 10, 2025

    1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305-4 120-240V 50/60Hz, item # 06OS0004CX6], [1 Ser CX 311-4 120-240V 50/60Hz CE, item # 807OS0004CX5], [1 Ser CX 311-4 120-240V 50/60Hz, item # 807OS0004CX6], [1 Ser CX 350-4 120-240V 50/60Hz, item # 807OS0400CX6], [1 Ser CX UVA1-4 120-240V 50/60Hz, item # 807OS0400CX6A1]

    FDA Recall
    Open, Classified ·Daavlin Distributing Company·Product code FTC·April 26, 2022

    SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

    FDA Recall
    Completed ·SynCardia Systems LLC·Product code LOZ·August 1, 2023

    Nobel Biocare N1 TiUltra TCC NP 3.5x13mm

    FDA Recall
    Open, Classified ·Nobel Biocare Vastra Hamngatan 1 Goteborg Sweden·Product code DZE·July 25, 2022

    NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code NHA·July 19, 2019

    . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function

    FDA Recall
    Open, Classified ·Nobel Biocare Vastra Hamngatan 1 Goteborg Sweden·Product code DZE·January 10, 2025