BEUDAMED
    27 results · 22ms · Sources: EU EUDAMED, US FDA

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    VITAL SUTURES, SUTUREX, CIRUGIA PERUANA

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

    CustoMed

    FDA UDI
    KENPAX INTERNATIONAL LIMITED·04895237141192·Gown No Reinforced

    Osstell SmartPeg Type 106

    FDA UDI
    Osstell AB·09010522002230·ISQ Measurement Peg

    Michel Wound Clips

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896120228·Michel Wound Clips Stainless Steel (100 Per Box)

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540133724·LINDEMANN BURR, MEDIUM

    DEBAKEY CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921007800·DEBAKEY CLAMP ANGLED BACK

    INTERACTIVE PRECISION IO SCAN ADAPTER

    FDA Adverse Event
    Malfunction ·IMPLANT DIRECT SYBRON MANUFACTURING, LLC·Product code NDP·December 7, 2018

    TROCHANTERIC NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REPROCESSED TROCARS, MODEL B5LT AND CB5LT

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·September 16, 2014

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 19, 2011

    All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Affected products include: Model 100540 Fleximount SGL Ceiling, Serial No.''s less than SC995486 Model 100740 SGL Ceiling CS II, Serial No''s less than SCCS990745 Model 100580 SGL Trolley, Serial No.''s less than TRS962633 Model 100780 SGL Trolley OP II, Serial No.''s less than STOP97417 Model 102540 SGL Ceiling OP II, Serial No.''s less than SCOP003354.

    FDA Recall
    Terminated ·Burton Medical Products Corp·Product code KZF·February 19, 2004

    Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 24, 2018

    Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 1, 2025

    Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020