BEUDAMED
    16 results · 22ms · 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 ×

    MALIBU SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 19, 2014

    Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code NKB·January 22, 2014

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496061342·BURLESQUE 70, SIZE ML, BLU NAVY, GRADUATED COMP...

    P.O.P. PAIN KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 13, 2025

    HORIZON TI SMALL LIGATING CLIPS 6/CART 180/BOX

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code FZP·April 10, 2013

    CARESCAPE

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES·Product code MHX·June 9, 2008

    SYNCHRON CX9 ALX

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJC·April 18, 2011

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·October 31, 2023

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·October 31, 2023

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPT·February 19, 2026

    HEARTMATE 3 SYSTEM CONTROLLER, US

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·May 16, 2019

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015