BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180194373·GUYON Metal Catheters For Women 14 Fr.

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158211926·DIRECTOR GROOVED 5.75"

    INTREPED, Intraosseous Fusion Device

    FDA UDI
    Auxano Medical LLC·00850055649576·INTREPED 10x14 implant

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193109084·HA PEEK EVOS Straight, ,14mmx11mmx 30mm , FLAT ...

    SURESIGNS VS2+ NBP/SPO2/WIRELESS

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code MHX·August 26, 2021

    BOND BONE

    FDA 510(k)
    FDA Class 2 ·Dental

    HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD VENFLON¿ PRO SAFETY NEEDLE PROTECTED IV CANNULA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·June 15, 2023

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code MMH·May 14, 2013

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code FFL·June 2, 2011

    7.0MM TI PANGEA POLYAXIAL SCREW

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code KWP·August 12, 2008

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    BD VENFLON PRO SAFETY SAFETY VENOUS INDWELLING CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·June 19, 2023

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    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