BEUDAMED
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    PIEZOSURGERY TOUCH

    FDA 510(k)
    FDA Class 2 ·Dental

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05055343897348·Femoral Posterior Augment 5 mm Sizes 1 & 2

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517636560·CoRoent Ant TLIF PEEK, 12x12x32mm 12°

    JOBST UltraSheer

    FDA UDI
    BSN MEDICAL, INC.·00035664223229·ULTRA SHEER 20-30 MM HG THIGH W/DOT BAND CLOSED...

    SURGISTAR

    FDA UDI
    SURGISTAR, INC.·00878799000248·

    Bernafon

    FDA UDI
    Bernafon AG·05711584022771·MD3 NR, PS GB MONDO 3

    MDT Diamond Coated Dental Burs -Sterile

    FDA UDI
    M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·67291046372342·FG Rotary diamond instrument for dental applica...

    MDT Diamond Coated Dental Burs -Sterile

    FDA UDI
    M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·67291046160000·FG Rotary diamond instrument for dental applica...

    INNOVA AND INNOVA 2000 S

    FDA 510(k)
    FDA Class 2 ·Radiology

    STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 9, 2017

    GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 4 / 10 MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 16, 2019

    - Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322 - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347 - Fast Cutting Drill Bit 2.0mm Ref. FDB 2.0 Lot 122289, 122322 - Midas Rex Metal Cutting Drill Bit 3.0mm x 18.3mm Ref. MC30 Lot 122347 Orthopedic manual surgical instrument

    FDA Enforcement
    Class II ·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013

    - Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665 - Cannulated Drill Bit, for 3.0mm Cannulated Screws, 1.2mm Cannulation, Quick Coupling 2.0mm x 150mm Ref. 310.221 Lot 122289 - Drill Bit, For Modular Hand System, Quick Coupling 2.8mm x 165mm Ref. 310.288 Lot 122322 - Drill Bit, Quick Coupling (Gold) 2.5mm Ref. DB-2.5 Lot 122289, 122322 - Egg Micro Bur, 10 Flute, Stainless Steel 4.0mm Ref. 1608-2-35 Lot 122429, 122347 - Hall Micro Bur, Oval, Long, 8-Flute, Carbide 4.0mm x 8.0mm Ref. 5092-136 Lot 123353 - Micro Bur, Round, Stainless Steel 3.2mm Ref. 1608-2-11 Lot 122447, 122347 - Oval Bur, Fast Cutting, 8-Flutes, Carbide, 44.5mm Total Length, 18.6mm Exposure 4.0mm x 7.9mm Ref. 227-10-62 Lot 122411 - Oval Bur, Solid, 8-Flute, Medium, Head Length: 7.7mm, Carbide 4.0mm x 48mm Ref. 5300-10-901 Lot 122647 - Oval Cutting Carbide Bur, Medium, (8-Flute) 4.0mm Ref. 5091-136 Lot 123353, 122454 - Round Bur, Medium, Solid 8-Flute, Carbide 4.0mm x 48.3mm Ref. 5300-10-511 Lot 122665 - Round Bur, Micro, 8-Flute, Exposure: 28.2mm Stainless Steel 2.4mm x 54mm Ref. 1608-2-9 Lot 122447 - Twist Drill, Quick Coupling 110mm 2.5mm Ref. 310.25 Lot 122289, 122322 - Wire Pass Drill Bit 1.5mm Ref. 1608-2-59 Lot 122511 Surgical instrument motors and accessories/attachments

    FDA Enforcement
    Class II ·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013

    EXCLAIM 8

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 15, 2013

    INVERSE/REVERSE SCREW SYSTEM, 4.5-30

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSD·September 18, 2014

    SYNCHRON CX9 ALX

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJC·June 13, 2011

    GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 17 MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 26, 2021

    PERITX DRAINAGE BAG

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·April 3, 2026

    - Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665 - Cannulated Drill Bit, for 3.0mm Cannulated Screws, 1.2mm Cannulation, Quick Coupling 2.0mm x 150mm Ref. 310.221 Lot 122289 - Drill Bit, For Modular Hand System, Quick Coupling 2.8mm x 165mm Ref. 310.288 Lot 122322 - Drill Bit, Quick Coupling (Gold) 2.5mm Ref. DB-2.5 Lot 122289, 122322 - Egg Micro Bur, 10 Flute, Stainless Steel 4.0mm Ref. 1608-2-35 Lot 122429, 122347 - Hall Micro Bur, Oval, Long, 8-Flute, Carbide 4.0mm x 8.0mm Ref. 5092-136 Lot 123353 - Micro Bur, Round, Stainless Steel 3.2mm Ref. 1608-2-11 Lot 122447, 122347 - Oval Bur, Fast Cutting, 8-Flutes, Carbide, 44.5mm Total Length, 18.6mm Exposure 4.0mm x 7.9mm Ref. 227-10-62 Lot 122411 - Oval Bur, Solid, 8-Flute, Medium, Head Length: 7.7mm, Carbide 4.0mm x 48mm Ref. 5300-10-901 Lot 122647 - Oval Cutting Carbide Bur, Medium, (8-Flute) 4.0mm Ref. 5091-136 Lot 123353, 122454 - Round Bur, Medium, Solid 8-Flute, Carbide 4.0mm x 48.3mm Ref. 5300-10-511 Lot 122665 - Round Bur, Micro, 8-Flute, Exposure: 28.2mm Stainless Steel 2.4mm x 54mm Ref. 1608-2-9 Lot 122447 - Twist Drill, Quick Coupling 110mm 2.5mm Ref. 310.25 Lot 122289, 122322 - Wire Pass Drill Bit 1.5mm Ref. 1608-2-59 Lot 122511 Surgical instrument motors and accessories/attachments

    FDA Recall
    Terminated ·Surgical Instrument Service And Savings, Inc.·Product code GFF·May 3, 2013