BEUDAMED
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    FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964151507·Endo Carry-on Procedure Kit contains Intercept ...

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890106360·Zirlux Titanium Esthetic Abutment Posterior com...

    Dentalor 60

    FDA UDI
    Cendres+Métaux SA·97640173080315·Dentalor 60

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0106160·Trial, 26 x 16mm, 8 Degree, Tapered, Straight

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036008536·

    C-REACTIVE PROTEIN ANTISERUM KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    STRYKER TRAUMA PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CADD

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·March 23, 2022

    YPSOPUMP INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 4, 2025

    YPSOPUMP INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 4, 2025

    CADD MEDICATION CASSETTE

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·July 14, 2022

    CADD

    FDA Adverse Event
    Malfunction ·NULL·Product code FPA·August 17, 2021

    CADD MEDICATION CASSETTES

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·June 6, 2022

    DELTA CER HEAD 11/13 36MM +6

    FDA Adverse Event
    Injury ·DEPUY IRELAND ? REG. # 9616671·Product code LZO·March 19, 2013

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·February 24, 2011

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

    9) Signa Excite 1.5 T (Excite II) (K013636 Signa Infinity MR System with EXCITE Technology) Signa Infinity MR System with EXCITE (K013636 Signa Infinity MR System with EXCITE Technology) The GE Signa@ Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa@ Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa@ Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024