BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    Fingertip Pulse Oximeter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    SYNTHES (U.S.A.) LP·10886982153265·5.0MM LOCKING SCREW SELF-DRILLING 30MM

    Votion®

    FDA UDI
    Ortho Organizers, Inc.·00190707113490·Votion .018 MC LR4 HK G/O -12T 2A 0O (10PK)

    Votion

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730007803·Votion 018 MC LR4 HK G/O -12T 2A 0O (10PK)

    ACE BIO WIN TIBIAL NAILING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROULTRA PIEZO ULTRASONIC

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 6, 2025

    CLARIUS ULTRASOUND SCANNER

    FDA Adverse Event
    Malfunction ·CLARIUS MOBILE HEALTH CORP.·Product code IYN·October 17, 2024

    SERVO-S

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·May 27, 2019

    METS PROXIMAL FEMUR REPLACEMENT IMPLANT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD·Product code JDI·October 24, 2014

    AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·May 8, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 16, 2011

    36MM MODULAR HEAD TYPE 1 TAPER STANDARD

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·March 15, 2017

    EPOLY 36MM RINGLOC LINER MROM SZ25

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·March 15, 2017

    REGENEREX RINGLOC 60MM MULTI HOLE ACETABULAR CUP SIZE 25

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·March 15, 2017

    MLRY-HD LAT POR FMRL 12X165MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·January 28, 2021

    M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER STANDARD NECK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·October 5, 2016

    M2A 38MM ONE-PIECE CUP 38MM X 56 O.D.

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·March 15, 2017

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 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.·May 3, 2017