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

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    ENDOSCOPIC RETRIEVAL DEVICE

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

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564031402·Set Up Pack, Minor

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450190661·

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197029254·O'Brien Suture Scissors angled...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197029223·O`Brien Ligature Scissor 9,5 cm...

    FUKUDA DENSHI DYNASCOPE MODEL DS-5700

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MULTI FRAME WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MCLEAN-RING NASOJEJUNAL FEEDING TUBE SET

    FDA Adverse Event
    Injury ·COOK INC·Product code KNT·November 10, 2021

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT·Product code DTB·May 9, 2013

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·May 26, 2011

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·August 15, 2008

    SAFESHEATH II 9F

    FDA Adverse Event
    Malfunction ·OSCOR INC.·Product code DYB·August 10, 2022

    REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·March 19, 2014

    MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software

    FDA Enforcement
    Class II ·Ongoing·Auris Health, Inc·February 25, 2026

    Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.

    FDA Enforcement
    Class II ·Ongoing·AURIS HEALTH INC·October 16, 2024

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 30, 2025