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

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    Sensuva Premium Silicone Personal Lubricant

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    NuVasive

    FDA UDI
    Nuvasive, Inc.·00195377046826·NTS Slot Tube, 22x60mm Beveled

    RESTORIS, PST, Mako

    FDA UDI
    MAKO SURGICAL CORP.·00848486030964·Offset Shell Impactor

    Packed 5D Plus Scanning Unit, RMA

    FDA UDI
    Align Technology, Inc.·00816063021001·Packed 5D Plus Scanning Unit, RMA

    NA

    FDA UDI
    SYNTHES (U.S.A.) LP·10886982152442·5.0MM LCKNG SCREW SLF-DRLG W/T25 STARDRIVE RECE...

    RESTORIS PST MAKO OFFSET SHELL IMPACTOR

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·June 23, 2016

    RESTORIS PST MAKO OFFSET SHELL IMPACTOR

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·October 17, 2017

    RESTORIS PST MAKO OFFSET SHELL IMPACTOR

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·December 19, 2017

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 16, 2023

    AYCAN MOBILE

    FDA 510(k)
    FDA Class 2 ·Radiology

    WIENER LAB. UREA UV CINETICA AA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 15, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014

    AMPHIRION DEEP PTA BALLOON CATHETER

    FDA Adverse Event
    Injury ·INVATEC SPA·Product code DQY·July 9, 2013

    DEKA LIPOAI

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 4, 2025

    POLYAXIAL CORTICAL SCREW 5.0 X 35

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code NKB·December 27, 2019

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015