BEUDAMED
    15 results · 35ms · Sources: EU EUDAMED, US FDA

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    GAMMAPLAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00510221·

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496051022·MARLENE POIS 70, SIZE M, NERO, GRADUATED COMPRE...

    Needle Holder

    FDA UDI
    KATENA PRODUCTS, INC.·00841668115916·NeedleHldr, Str W/O Lock, Std, Titanium

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011051022000·Exchange Tip,Straight

    ENDO LINEAR CUTTERS-ECHELON 60MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GDW·June 13, 2006

    BIOUNIVERSAL PDF

    FDA 510(k)
    FDA Class 2 ·Dental

    BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061

    FDA 510(k)
    FDA Class 2 ·Immunology

    BD VACUTAINER® CRITICAL CARE PRESET SYRINGE WITH ATTACHED NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 27, 2017

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·April 10, 2013

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·April 4, 2011

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008

    13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.

    FDA Enforcement
    Class II ·Terminated·Cairn Diagnostics·February 24, 2021

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018