BEUDAMED
    23 results · 21ms · Sources: EU EUDAMED, US FDA

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    Promisemed Insulin Pen Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010511324·WATANABE PIN PULLER LARGE ...

    Salvo® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642174618·9.5 x 50 mm Bone Screw, Cannulated, 3 mm Pitch

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319757543·Masing Septum Elevator 8", double-ended, 3.3mm ...

    ENGPLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    LIQUID BANDAGE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Maestro

    FDA UDI
    STRYKER CORPORATION·04546540469212·PD Series Fixed Dura Guard

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    NEXTAR SPINE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·October 22, 2008

    XACT CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIM·August 12, 2011

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 3, 2013

    ALINITY I TOXO IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·November 18, 2024

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·December 2, 2020

    Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·December 2, 2020

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    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

    Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.

    FDA Enforcement
    Class II ·Terminated·Luminex Corporation·August 19, 2020