BEUDAMED
    18 results · 28ms · Sources: EU EUDAMED, US FDA

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    SANDMAN SD20 AMPLIFIER

    FDA 510(k)
    FDA Class 2 ·Neurology

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00401131·

    Premier

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6911040113·RING PESSARY W/O SUPPORT #3

    20GA Illuminating Laser Probe, SMA906

    FDA UDI
    Peregrine Surgical, Llc·00632307002007·20GA Illuminating Laser Probe, SMA906

    NAV SOLID TAP FOR 6.5mm FASTENER

    FDA UDI
    Osteocentric Technologies, Inc.·00810097803558·NAV SOLID TAP FOR 6.5mm FASTENER

    PEN NDL 31GA 8MM 100 BX 1200 LA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·June 2, 2021

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193023162·B-P HIP FEMORAL STEM W/O HEAD, W/ BIOCOAT & ULT...

    LASER MECHANISMS LASER SCANNING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PROVEN KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 8, 2013

    UNKNOWN DEPUY HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·May 7, 2008

    CONTAK RENEWAL

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 5, 2011

    Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Millennium Surgical, Symmetry Surgical, Accutome, Boss Instruments, and Medline Industries brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    PKG, 5MM INSERT, MARYLAND DISSECTING FORCEPS, CURVED LEFT, 45CM, P/N 00250080578 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014

    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 1, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013