BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    NA

    FDA UDI
    Richard Wolf GmbH·04055207013908·FIBER LIGHT CABLE Ø 4.5MM TL 2.3M

    SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BD VACUTAINER® PLASTIC MICROBIOLOGY C&S TUBE KIT WITH TRANSFER STAW/BD HEMOGARD¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JSM·December 1, 2017

    AESCULAP SURGICAL INSTRUMENTS

    FDA Adverse Event
    Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019

    AESCULAP SURGICAL INSTRUMENTS

    FDA Adverse Event
    Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·November 27, 2019

    UNKNOWN

    FDA Adverse Event
    WILLIAM COOK EUROPE·Product code DTK·October 27, 2015

    BD VACUTAINER® PLASTIC MICROBIOLOGY C&S TUBES KIT, TRANSFER STRAW/BD HEMOGARD¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JSM·November 29, 2017

    BD VACUTAINER® C & S BORIC ACID SODIUM KIT BORATE / FORMED

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JSM·November 7, 2017

    ST104 TRANSPORT OBS 3/07

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 16, 2013

    RESTORE RECHARGABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·April 4, 2011

    MEDISYSTEMS REDI-SET

    FDA Adverse Event
    Injury ·MEDISYSTEMS CORPORATIONS·Product code FKJ·June 17, 2008

    PROGAV SYS PED.W/SA 15 A.PRECHAMBER

    FDA Adverse Event
    Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·April 4, 2019

    PROGAV 2.0 SYS PED.W/SA15 A.PRECHAMBER

    FDA Adverse Event
    Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·August 6, 2020

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    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

    Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

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