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

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    Coresculpt & Magsculpt

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    POYA 3.5mm Posteromedial Proximal Tibia Plate, 13 Hole, Right

    FDA UDI
    Bonebridge AG·07640187462586·

    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code FMZ·June 30, 2021

    G185

    FDA UDI
    RESEARCH INSTRUMENTS LIMITED·05060554120109·Incubator for assisted reproduction

    G185

    FDA UDI
    RESEARCH INSTRUMENTS LIMITED·05060554120116·Incubator for assisted reproduction

    G185

    FDA UDI
    RESEARCH INSTRUMENTS LIMITED·05060554120086·G185 Incubator for assisted reproduction

    G185

    FDA UDI
    RESEARCH INSTRUMENTS LIMITED·05060554120093·Incubator for Assisted reproduction

    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·August 25, 2021

    TriVerse Pin Grabber

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215099640·

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101344·R Tibial Baseplate Cemented Stemmed Sz 4 Insert B

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523102112·R Tibial Baseplate Cemented Keeled Sz 4

    SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARDIOX FLOW DETECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TPRLC XR FP TYPE1 PPS

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code OQG·February 18, 2021

    TPRLC 133 FP TYPE1 PPS HO

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWL·February 18, 2021

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 26, 2021

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 15, 2011

    DRILL GUIDE - OVERDRILL Ø2.7MM & Ø3.5MM FOR 2.7 & 3.5 SCREWS

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA SELZACH·Product code HRS·November 4, 2014

    DERMABOND TOPICAL SKIN ADHESIVE

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code MPN·July 12, 2013

    A200 KNEE SYSTEM

    FDA Adverse Event
    Injury ·RENOVIS SURGICAL TECHNOLOGIES, INC.·Product code JWH·September 16, 2016