BEUDAMED
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    ELS CANNULA (KIT), MODEL M1210-88,M1510-88

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496002857·NAOMI 30, SIZE ML, BLU SCURO, GRADUATED COMPRES...

    Nellix® EndoVascular Aneurysm Sealing System

    FDA UDI
    Merit Medical Systems, Inc.·00884450265574·

    PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ETA·February 19, 2016

    RANGER II M6, MODEL IN-888WNL

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BROOKER TIBIA NAILS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    XIA SCREW 6, 5 X 40

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code MNI·May 11, 2011

    RHK SEGMENTAL SHORT YOKE

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·December 7, 2016

    SM304 M-SERIES W/ZOOM

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code INK·March 13, 2013

    DEPUY ASR FEM IMPLANT SZ 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 16, 2011

    PROSTIVA

    FDA Adverse Event
    Other ·MPROC, VILLALBA·Product code KNS·February 25, 2008

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019