BEUDAMED
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    IntraMarX 3D Radiopaque Marker

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DJO SURGICAL

    FDA Adverse Event
    Injury ·ENCORE MEDICAL L.P.·Product code FZX·December 9, 2025

    OptoMonitor 3

    FDA UDI
    Opsens Inc·07540184011063·

    Diversatek Healthcare

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·M78312011060·Basic Endoscopy Procedure Kit

    16PW - Krispy Kreme FAK - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015064·16PW - Krispy Kreme FAK - Poly White

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528114223·2.4 FULLY THREADED SCREW, AO DRILL GUIDE

    MODIFICATION TO TSRH SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HAMILTON-C3

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·February 9, 2024

    SPECIAL, SHORTENED RSP BASEPLATE DRILL_SCREW GUIDE

    FDA Adverse Event
    Injury ·ENCORE MEDICAL L.P·Product code LXH·April 28, 2023

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 27, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·July 1, 2011

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·July 2, 2013

    SPECIAL, SHORTENED RSP BASEPLATE DRILL_SCREW GUIDE

    FDA Adverse Event
    Malfunction ·ENCORE MEDICAL L.P.·Product code LXH·June 21, 2023

    Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF; Cartons of 3 units labeled in part: REF 46300223; Vaporization electrode, sterile; 4mm telescope 30/25/12; only for continuous irrigation sheath 24,5 Fr.; Lot 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium. It can also be used for monopolar resection if necessary.

    FDA Recall
    Terminated ·Richard Wolf Medical Instruments Corp.·Product code FJL·September 18, 2013

    RSP

    FDA Adverse Event
    Malfunction ·ENCORE MEDICAL L.P·Product code FZX·September 12, 2022

    Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF; Cartons of 3 units labeled in part: REF 46300223; Vaporization electrode, sterile; 4mm telescope 30/25/12; only for continuous irrigation sheath 24,5 Fr.; Lot 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium. It can also be used for monopolar resection if necessary.

    FDA Enforcement
    Class II ·Terminated·Richard Wolf Medical Instruments Corp.·November 13, 2013

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020