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

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    DIALYSATE METER, MODEL D-6

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694001854·30mm 4 Hole Straight Rigid Plate

    Bump-R-Sleeve Tubing

    FDA UDI
    TP ORTHODONTICS INC·00192029039007·Grey

    Manta Ray™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981056209·Plate - 2 Level - 37 mm

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTL.·Product code MNI·October 14, 2011

    ELECSYS HCG+B CALCHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·November 11, 2011

    NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code LZO·April 15, 2024

    3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/14MM

    FDA Adverse Event
    Injury ·SYNTHES, USA·Product code HRS·May 8, 2013

    ABBOTT M2000SP

    FDA Adverse Event
    Malfunction ·ABBOTT MOLECULAR, INC.·Product code JJH·September 18, 2014

    6.5MM TI CANCELLOUS LOCKING SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code KWQ·May 16, 2011

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose

    FDA Recall
    Terminated ·Nephros Inc·Product code ND·October 28, 2013

    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·October 5, 2022

    1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH -6 filters per box ; item no. 10-0237 Manufactured by : Nephros, Inc. 41 Grand Ave, River Edge, NJ 07661 Assembled at MEDICA 41036 Medolla, Italy The Nephros SafeSpout and SafeShower are intended to filter water for washing and drinking. They are intended to be installed at the end of a standard sink faucet or shower hose

    FDA Enforcement
    Class I ·Terminated·Nephros Inc·December 25, 2013

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015