BEUDAMED
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    Hubly Electric Drill (H100)

    FDA 510(k)
    FDA Class 2 ·Neurology

    ENDO MODEL M

    FDA Adverse Event
    Malfunction ·WALDEMAR LINK GMBH & CO. KG·Product code KRO·September 11, 2024

    ENDO MODEL M

    FDA Adverse Event
    Malfunction ·WALDEMAR LINK GMBH & CO. KG·Product code KRO·September 13, 2024

    ODI 7.0MM CANNULATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    FRESENIUS 2008K HEMODIALYSIS SYSTEM OLC/DIASAFE PLUS

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·October 24, 2014

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·August 11, 2011

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 16, 2013

    POWERHEART G5 KIT,SEMI, US ENG/LA ESP, CPRD

    FDA Adverse Event
    Malfunction ·CARDIAC SCIENCE CORPORATION·Product code MKJ·November 20, 2023

    EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·June 4, 2018

    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

    CURVED-TIP STAPLER 30,IS4000; Model number 470530; 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

    The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the system and its primary function is to support the instrument arms and camera arm. The X/Xi Instrument Arm Drape is intended to be used with the instrument arms of the PC as a sterile barrier during clinical procedures, and makes the instrument arms sterile and suitable for surgery. X/Xi Instrument Arm Drapes are sterile unless the package is opened or damaged, and are indicated for a single use. The drapes are placed onto the instrument arms by two users (one sterile and one non-sterile)in tandem, with the non-sterile user leading the placement via drape cuff pockets.

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·September 21, 2021

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

    HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019