BEUDAMED
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    Perfectio LED infrared device

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

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776189648·AI Female Fitting Ass'y nonperm clips

    HairCheck-DT (Cocaine)

    FDA UDI
    Quest Diagnostics·00868586000216·HairCheck-DT (Cocaine) is an ELISA test kit use...

    AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FINE JECT INSULIN PEN NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ADVANCE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC·Product code DXE·September 9, 2019

    SPRINT QUATTRO

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·June 7, 2013

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

    PLUM XL3 PLS MIC/MAC

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 23, 2011

    STENT - VASCULAR RECONSTRUCTION

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code NJE·January 17, 2024

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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