BEUDAMED
    17 results · 30ms · Sources: EU EUDAMED, US FDA

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    HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PowerPICC SOLO

    FDA UDI
    Bard Access Systems, Inc.·00801741152627·Catheter Placement Kit

    Deploy™ Expandable Interbody System

    FDA UDI
    Southern Spine LLC·00815351022225·Lumbar Expandable Cage, 0 Degree, 28mm Length, ...

    GeneXpert®

    FDA UDI
    CEPHEID·07332940007195·Xpress System

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694044936·PrimaLOK SP 28mm Medium Boxless Implant, Sterile

    primaLOK SP

    FDA UDI
    Wenzel Spine, Inc.·00813210021785·primaLOK SP 28mm Medium Boxless Implant, Steril...

    RENAFLO II HF 2000 HEMOFILTER

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

    HARDYDISK, CEFAZOLIN, 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VANGUARD PFR FEMORAL LT SM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRR·May 17, 2018

    FILLER, CALCIUM SULFATE PREFORMED PELLETS

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code MQV·November 21, 2014

    *

    FDA Adverse Event
    Other ·ZIMMER SPINE, INC.·Product code MCV·August 20, 2004

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·February 24, 2011

    EMBRACE PUMP

    FDA Adverse Event
    Malfunction ·ROSS PRODUCTS DIVISION·Product code LZH·February 18, 2008

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

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