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

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    Therm-X (Home); Therm-X (AT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776182069·Bruns Curette hollow hdl str oval

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780187370·Integra® Jarit® Bruns Oval Cup Curette, 9", Str...

    DD Bio Splint P HI

    FDA UDI
    Dental Direkt GmbH·EDDIK401251·DD medical polymers (PMMA), made from PMMA, are...

    Delta®

    FDA UDI
    MEDTRONIC PS MEDICAL, INC.·00613994908100·SHUNT 24012-5 DELTA UNITIZED SML

    Delta®

    FDA UDI
    MEDTRONIC PS MEDICAL, INC.·00643169472846·SHUNT 24012-5 DELTA UNITIZED SML

    Ballard* Multi-Access Port Replacement Catheter

    FDA UDI
    Avanos Medical, Inc.·00609038200736·BALLARD* Multi-Access Port Catheter, Replacement

    BETA

    FDA UDI
    Gc Orthodontics America Inc.·E53573K24017251·BETA-TITA KEYHOLE 17X25 24MM(5 PACK)(SO)

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·August 1, 2002

    SENOGRAPHIC STEREO

    FDA 510(k)
    FDA Class 2 ·Radiology

    NEW STETIC DENTAL AMALGAM ALLOY

    FDA 510(k)
    FDA Class 2 ·Dental

    JDICON PLUS

    FDA Adverse Event
    Injury ·J DENTAL CARE SRL·Product code DZE·January 9, 2026

    CLINITEK STATUS+

    FDA Adverse Event
    SIEMENS HEALTHCARE DIAGNOSTICS·Product code JIL·May 16, 2016

    INTERLINK T-CONNECTOR EXTENSION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 24, 2008

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 9, 2011

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTM·July 18, 2013

    Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code PUB·November 15, 2024

    Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024