BEUDAMED
    14 results · 21ms · 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 ×

    NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489125563·PowerChem Neoprene Exam Gloves, Extra Extra Large

    ACCESS SEQUESTRATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MITEK 2GII MENISCAL REPAIR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STEM: AMISTEM HA COATED STD SIZE 2

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2019

    2520274-2013-01755

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·April 23, 2013

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Malfunction ·WAVELIGHT GMBH·Product code LZS·April 8, 2011

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWP·July 10, 2008

    BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 26, 2020

    COCR BALL HEAD 12/14 Ø 28 SIZE XXL +10.5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·July 12, 2017

    ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.

    FDA Enforcement
    Class II ·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012

    METRx II Tube, 14mm x 8cm stainless steel tubular retractor, Part No. 9569665

    FDA Recall
    Terminated ·Medtronic Sofamor Danek Instrument Manufacturing·Product code LXH·January 25, 2006

    Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015