BEUDAMED
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    SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780180036·Integra® Jarit® Olsen-Hegar Needle Holder, 4-3/...

    Diversatek Healthcare

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·M7831201490·Endoscopy Basic Procedure Kit

    GAUNYING INFRARED LAMP

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TROJAN PLEASURE PACK LUBRICATED CONDOMS

    FDA Adverse Event
    Injury ·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·June 15, 2023

    CONSERVE(R) PLUS CUP

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·May 20, 2013

    GORE® TAG® THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·September 25, 2014

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·June 3, 2011

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 29, 2025

    GMK-REVISION TIBIAL AUGMENTATION SIZE 2/10MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·June 23, 2023

    SERVO-I BASE UNIT

    FDA Adverse Event
    Injury ·MAQUET CRITICAL CARE AB·Product code CBK·December 5, 2023

    SERVO-I BASE UNIT

    FDA Adverse Event
    Injury ·MAQUET CRITICAL CARE AB·Product code CBK·December 4, 2023

    GMK-HINGE FEMORAL COMPONENT SIZE 2 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·February 7, 2022

    GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 29, 2019

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 4, 2019

    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