BEUDAMED
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    STERILE WATER & SALINE IN PLASTIC BTL.

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Sphero Attachment

    FDA UDI
    Preat Corporation·00842092115008·Sphero Block Abutment Nobel Active 3.0 x 3mm (2...

    CORDIS 13F CATHETER SHEATH INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AESCULAP ENDOSCOPIC CLIP SYTEM

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

    APC PLUS ADHESIVE

    FDA Adverse Event
    Injury ·3M UNITEK·Product code DYW·June 7, 2007

    CONSERVE(R) PLUS HA CUP

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code KWA·May 8, 2014

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·October 17, 2012

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 12, 2010

    Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06

    FDA Recall
    Terminated ·Dutch Ophthalmic USA, Inc.·Product code HMX·February 25, 2021

    Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC

    FDA Recall
    Open, Classified ·Dutch Ophthalmic USA, Inc.·Product code HQF·April 14, 2021

    Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)

    FDA Recall
    Open, Classified ·D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands·Product code HQC·January 15, 2024

    Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)

    FDA Recall
    Open, Classified ·D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands·Product code HQC·January 15, 2024

    Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)

    FDA Recall
    Open, Classified ·D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands·Product code HQC·January 15, 2024

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·March 22, 2023