BEUDAMED
    18 results · 38ms · Sources: EU EUDAMED, US FDA

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    ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PREMICRON NONABSORBABLE PET SURGICAL SUTURE

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

    ELECTROSTATIC HYDROPHOBIC BREATHING FILTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FLOGARD

    FDA Adverse Event
    Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·May 3, 2013

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 3, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 27, 2011

    PREMICRON GREEN 4/0(1,5)4X45 HR13 TOM

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·January 29, 2020

    PREMICRON GREEN 2/0 (3) 75CM HR26 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAW·June 28, 2019

    NONIN

    FDA Adverse Event
    Other ·CAREFUSION 211, INC.·Product code DQA·December 13, 2010

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 2025

    PREMICRON GREEN 2/0 (3) 30CM SKR19(M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·February 3, 2020

    PREMICRON G/W 2/0(3)4X90CM2XHRC20MPF6MLP

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019

    PREMICRON GREEN 2/0 (3) 75CM HR26 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019

    PREMICRON G/W 2/0(3)4X90CM2XHRC20MPF6MLP

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019

    CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012