BEUDAMED
    23 results · 24ms · Sources: EU EUDAMED, US FDA

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    Geneva

    FDA 510(k)
    FDA Class 2 ·Radiology

    36M - Navajo Tribal Utility Authority

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588012797·36M - Navajo Tribal Utility Authority

    Navajo Tribal Utility Authority - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588012780·Navajo Tribal Utility Authority - 18 Metal

    LIPOSUCTION CANNULA

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B0992012720·LIPOSUCTION CANNULA MERCEDES STYLE

    Duster

    FDA UDI
    WISDOM MEDICAL TECHNOLOGY, LLC·00859337007189·end emitting laser fiber, single use, 272 micro...

    Adler Instrument Company

    FDA UDI
    Adler, Inc.·00810123208005·Nelson Scissor Curved TC BL75mm (12-1/4)

    XIA SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SIB CATHETER, MODEL 61-7005

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

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 28, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·October 27, 2014

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·August 3, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 2, 2013

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·November 27, 2012

    TALENT TAA

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·February 11, 2014

    RELIANT BALLOON

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code DQY·February 11, 2014

    VALIANT

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·February 11, 2014

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    FDA Adverse Event
    Injury ·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code MQP·February 5, 2018

    Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026