BEUDAMED
    19 results · 28ms · 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 ×

    LASERTOUCHONE (OTC)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Aspida

    FDA UDI
    ALPHATEC SPINE, INC.·00844856062931·16MM LUMBAR PLATE

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694001649·150mm x 300mm Mesh Plate

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869688536·MOSS VRS PSO Pliers Blade left

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100110001·IN-OVATION® C TGO 020X028 U5-5/L3-3 CS-BC HK

    PLANMED SOPHIE, PLANMED SOPHIE CLASSIC

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HUDSON ENDOTRACHEAL TUBE, CF, 8.0

    FDA Adverse Event
    Malfunction ·TELEFLEX·Product code BTR·July 31, 2014

    Widex

    FDA UDI
    Widex A/S·05706069871678·WIDEX MOMENT MRR2D (Dark cherry ) RC coil, mRIC...

    Widex

    FDA UDI
    Widex A/S·05706069971248·WIDEX MOMENT MBB2 (Dark cherry)

    Widex

    FDA UDI
    Widex A/S·05706069834598·WIDEX MOMENT MBB3D (Dark cherry)

    NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HRS·April 4, 2023

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP.·Product code FRN·April 29, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·September 18, 2014

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·May 16, 2011

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·March 9, 2023

    E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology

    FDA Enforcement
    Class II ·Terminated·Kreg Medical Inc.·June 12, 2013

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020