BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450226292·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0112090·Tap, Cannulated, 7.5 mm

    INFLATABLE PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FHW·May 22, 1997

    SCIMEDX PHASE II MPO IGG ANTIBODY EIA

    FDA 510(k)
    FDA Class 2 ·Immunology

    SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP.·Product code DQY·December 8, 2006

    SUMMIT DUOFIX TAP SZ5 HI OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 12, 2015

    RECLAIM DIST REAMER EXTENSION

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LXH·March 19, 2013

    PINNACLE MTL INS NEUT36IDX50OD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD·Product code KWA·March 4, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·March 11, 2008

    Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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