BEUDAMED
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    MEGA-DIASTIX

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NGAGE

    FDA UDI
    Orthofix US LLC·18257200073757·NGAGE 6-LOBE 13X17MM MESH, 10MM

    BED TRAY

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SOL SYS 8/12.0 LRG ST

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·April 21, 2014

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 20, 2007

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·September 26, 2012

    Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·September 19, 2011

    Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·September 19, 2011

    da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·September 19, 2011

    da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.0.0 (P4_B327) / 610112-327 / N/A

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·September 22, 2021

    da Vinci S Surgical System 8 mm Long instrument cannula, Part #:420004-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086,

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·March 9, 2007

    da Vinci S Surgical System 5 mm instrument cannula, Part #: 420011-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·March 9, 2007

    da Vinci S Surgical System 8 mm instrument cannula, Part #: 420002-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·March 9, 2007

    IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.

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

    8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·May 8, 2013

    8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·May 8, 2013

    IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000. Arm drapes protect equipment from contamination.

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

    8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·May 8, 2013

    INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·October 7, 2022