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

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    CO/CMD-1

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377068262·RELINE C Conn,3.5-4/4.5-5mm Top-Top Ang

    3M™ Unitek™

    FDA UDI
    3M COMPANY·30605861028234·3M™ Unitek™ Stainless Steel First Permanent Mol...

    Pediatric Front Closing Special Procedure Apron, Large, 14" x 31"

    FDA UDI
    Flow X Ray Corporation·00843696128357·Pediatric Front Closing Special Procedure Apron...

    MasterSeries

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746095122·DB BRACKET MASTER SERIES MAX 1ST/2ND BICUSPID 5...

    EASY MOVING PLUS, SM-XXHF-YY

    FDA 510(k)
    FDA Class 2 ·Radiology

    TD-4277 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 4277

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    90-0322 VAGINAL DELIVERY TRACEPAK

    FDA Adverse Event
    Malfunction ·DEROYAL INDUSTRIES, INC.·Product code KDD·December 7, 2001

    90-0322 VAGINAL DELIVERY TRACEPAK

    FDA Adverse Event
    Malfunction ·DEROYAL INDUSTRIES, INC.·Product code KDD·December 7, 2001

    90-0322 VAGINAL DELIVERY TRACEPAK

    FDA Adverse Event
    Malfunction ·DEROYAL INDUSTRIES, INC.·Product code KDD·December 7, 2001

    90-0322 VAGINAL DELIVERY TRACEPAK

    FDA Adverse Event
    Malfunction ·DEROYAL INDUSTRIEES, INC.·Product code KDD·December 7, 2001

    SIGMA PS CEM FEM SZ5 R

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS 121965·Product code JWH·June 27, 2014

    ACCLAIM ENCORE 2.25

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·October 25, 2010

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·January 7, 2013

    SMR GLENOSPHERE Ø 40MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·December 15, 2021

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

    ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·May 1, 2024