BEUDAMED
    19 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Knee+

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ormco

    FDA UDI
    ORMCO CORPORATION·00889989044331·CROWN-PERM LR 4 1ST MOLAR SST PK/5

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481125454·LOCATOR F-Tx Abutment for Anyridge Internal Con...

    “Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)

    FDA UDI
    Paonan Biotech Co.,Ltd.·04719878786980·T2 Cannulated Tap 4.5 mm

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481125393·LOCATOR R-Tx Attachment System, 3.5mm AnyRidge ...

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112731·BARRON VACUUM PUNCH 7.0MM

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·37613252250037·Bone Screws, MP, Cross-Pin

    Oxylight

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VISIONSEARCH 1

    FDA 510(k)
    FDA Class 2 ·Neurology

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 4, 2024

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·October 31, 2008

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code MMI·August 12, 2011

    UNIFY QUADRA CRT-D

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023

    Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018