BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    DUCERAM PLUS CERAMIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Premier

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6911040420·CUBE PESSARY W/ DRAINAGE HOLES #10

    Trilogy

    FDA UDI
    Respironics, Inc.·00606959043145·Trilogy Ventilator In-Use Device Bag

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291102281·SS Suture, 7 per sleeve

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981175641·Z-Rod, Dia. 5.5mm, Co-Cr, 420mm

    Medline

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10884389027981·FENESTRATED DRAPE W/TAPE, 18 X 26

    Toilet Support Arms

    FDA UDI
    Ropox A/S·05707581014765·

    C & B FORMULA

    FDA UDI
    AMERICAN TOOTH INDUSTRIES·D772ATI400404200·C & B FORMULA 4 OZ SHADE 20

    RUSCH MMG/O'NEIL CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·April 8, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·April 5, 2011

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN-BENNETT CORP·Product code CBK·May 7, 2008

    SPINAL ANESTHESIA KIT

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code BSP·November 6, 2018

    PKG, STRONG FORCEPS, FENESTRATED, P/N 0250080320. 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

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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

    NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2. 3.0T GEM Flex Coil 16-M Array, NC033000, GEHC part number 5430008-3. 3.0T GEM Flex Coil 16-S Array, NC034200, GEHC part number5430008-4. The 3.0T GEM Flex Coil (interface box and arrays) is used in conjunction with a 3.0T GE Magnetic Resonance Scanner

    FDA Enforcement
    Class II ·Terminated·NeoCoil, LLC·March 9, 2016