BEUDAMED
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    Efai Pacs Picture Archiving and Communication System Pro

    FDA 510(k)
    FDA Class 2 ·Radiology

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517194640·MaXcess Access Blade, 100mm Right

    AOS Cannulated Drill, Large Hudson 5.5mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665021905·

    TARGETING MODULE, TROCHANTERIC NAIL 125°/20cm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665010855·

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112700·BARRON VACUUM PUNCH 6.0MM

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102312·CULLER IRIS SPATULA 1.0MM

    Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)

    FDA 510(k)
    FDA Class 2 ·Dental

    I-BEAM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    VALIANT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·April 4, 2013

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 7, 2008

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 1, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 17, 2013

    FREESTYLE LITE

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code NBW·April 21, 2017

    epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.

    FDA Enforcement
    Class II ·Terminated·Epocal·August 21, 2013

    INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODE; S Cardiac Probe Gasper Instrument, Model IS2000, Part Number 420215-02; Product is manufactured and distributed by Intuitive Surgical, Inc. Sunnyvale, CA . The IS2000 CPG is used during cardiac ablation procedures.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·April 18, 2008

    Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·November 15, 2013

    Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·November 15, 2013

    STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device is indicated for adult and pediatric use. The device can be used with staple line or tissue buttressing material.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·July 14, 2016

    STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·July 14, 2016