BEUDAMED
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    SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDRAD® Spectris Solaris EP MR Injection System

    FDA UDI
    BAYER MEDICAL CARE INC.·00616258008837·"iCBC FOR SPECTRIS SOLARIS EP INJECTOR (60727757)"

    MEDRAD® Spectris Solaris EP MR Injection System

    FDA UDI
    BAYER MEDICAL CARE INC.·00616258022246·ICBC FOR SPECTRIS SOLARIS EP INJECTOR SYSTEM, F...

    12 x 80mm Anodized SI Implant

    FDA UDI
    Osteocentric Technologies, Inc.·00810097800069·12 x 80mm Anodized SI Implant

    Integrity-SI Fusion System

    FDA UDI
    Lincotek Medical LLC·B57112521012080D0·12 x 80 mm Anodized SI Implant

    Ti-Fix OLIF Spacer

    FDA UDI
    Tyber Medical, LLC·M695P30120800·Ti-Fix OLIF Spacer 30 x 12 x 8 (mm) x 0 °

    mahe medical GmbH

    FDA UDI
    mahe medical gmbh·04050659174344·6.5 Cancellous Bone Screw, hex, _x000D_...

    6.5 Cancellous Bone Screw, hex, St.Steel, L 80 mm

    FDA UDI
    mahe medical gmbh·EMAH00100120800·6.5 Cancellous Bone Screw, hex, St.Ste...

    INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BEHRING COAGULATION SYSTEM, MODEL BCS

    FDA 510(k)
    FDA Class 2 ·Hematology

    GOOD SAM CINCINNATI OH 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DWE·December 11, 2008

    TI CERVICAL SPINE LOCKING PLATE 77MM (69MM)

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code KWQ·March 20, 2013

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·February 28, 2011

    FREESTYLE FLAS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·May 14, 2007

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·February 21, 2025

    ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·August 15, 2013

    ACCOLADE PLUS TMZF HIP STEM #1

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·November 13, 2013

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code KWA·December 23, 2013

    Comprehensive RS Cleat CAP, Item No. 110300

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

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026