BEUDAMED
    17 results · 25ms · Sources: EU EUDAMED, US FDA

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    SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PINNACLE®

    FDA UDI
    B. BRAUN MEDICAL INC.·04046955772780·SCB 1000ML EVA MIXING CONT. SINGLE PACK

    1240 1 WAY VALVE

    FDA UDI
    HANS RUDOLPH, INC.·00874750009176·1240A 1WAY 10.5MMOD/7.5MMID PT

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506089602·WESTCOTT MICRO SCISSORS, STRAIGHT 4.5"

    Trephine

    FDA UDI
    ELLIQUENCE, LLC·00846338002329·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00846795000845·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024493506·

    InFill Lordotic TLIF

    FDA UDI
    PINNACLE SPINE GROUP, LLC·00814729025066·

    REPROCESSED DYONICS ARTHROSCOPIC SHAVERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ROUND FILTER POLYPROVPYLENE

    FDA Adverse Event
    Malfunction ·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014

    4F-80CM PREM SYNTEL CATHETER

    FDA Adverse Event
    Other ·APPLIED MEDICAL·Product code DXE·April 6, 2011

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021