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

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    FDA 510(k)
    FDA Class 2 ·Radiology

    ArgenZ HT+ 98x14 OM1

    FDA UDI
    ARGEN CORPORATION, THE·D818122026·Dental porcelain/ceramic restoration kit

    FAC-3 - Class B 21 White Cap - 3 Shelf Cabinet

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620268·FAC-3 - Class B 21 White Cap - 3 Shelf Cabinet

    RUSCH

    FDA UDI
    TELEFLEX INCORPORATED·14026704625861·KRYPTON BULBS (BOX OF 6), LARGE

    MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)

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

    SEASPINE SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INFUSE BONE GRAFT 12 MG

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code NEK·May 1, 2014

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·November 21, 2025

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON LABORATORIES IRELAND LTD.·Product code HQL·May 16, 2013

    ASR ACETABULAR CUPS 56

    FDA Adverse Event
    Injury ·DEPUY INTL. LTD.·Product code KWA·June 9, 2011

    CONTOUR CURVED CUTTER STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 14, 2008

    HANG&GO HT BASIC

    FDA Adverse Event
    Malfunction ·RAND S.R.L.·Product code LGZ·May 15, 2017

    Campy CVA Medium 100/PK, R01272

    FDA Enforcement
    Class II ·Ongoing·Remel, Inc·March 4, 2026

    EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·February 11, 2026

    Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium Closed Male Luer With Priming Cap, REF: 22000-B007T; Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, REF: 22600-0007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22602-B007T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded Texium With Priming Cap, REF: 22603-B007T; Bonded Texium Closed Male Luer with priming cap Back Check Valve 2 SmartSite Y-Sites, REF: 24010-0007T; SmartSite Bag Access Non-Vented 0.2 MicronFilter Bonded Texium Closed Low Sorbing Tubing (PE Lined) Male Luer with priming cap SmartSite Y-site, REF: 24301-0007T; SmartSite Bag Access Non-Vented Low Sorbing Texium Back Check Valve 2 SmartSite Y-Sites, REF: 24601-B007T. BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TEXIUMTM AND HANGER LOW SORBING, REF: 70001B-07T; BD 20-IN EXTENSION SET W/0.2 MICRON FILTER ONE SmartSite VALVE AND Texium, REF: 20350ET; BD Secondary Set 20 Drop Vented Non Vented With Texium & Hanger, REF: 40000-07T; BD 20 DROP SECONDARY SET SmartSite VALVE BAG ACCESS W/TEXIUM CLOSED MALE LUER HANGER, REF: 10013364T; BD 32-IN GRAV SET MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, REF: 4030B-07T; BD Texium Smartsite MICROBORE EXTENSION SET 60 IN, REF: 22005E-07T

    FDA Enforcement
    Class II ·Ongoing·BD SWITZERLAND SARL·June 18, 2025

    Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·July 27, 2022

    Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2-1/4" (57 mm) without Kit, 3) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-3/4, 2-3/4" (70 mm)

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·March 10, 2021

    Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style

    FDA Recall
    Open, Classified ·Healthmark Industries Co., Inc.·Product code OCU·March 12, 2026

    LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.

    FDA Recall
    Open, Classified ·Linkbio Corp.·Product code QHE·March 12, 2026

    Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code ODC·February 12, 2026