BEUDAMED
    39 results · 24ms · Sources: EU EUDAMED, US FDA

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    ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bur PM2-MIS P160 Mstick Ø3.0 St

    FDA UDI
    Bien-Air Surgery SA·17630055512151·

    Oticon

    FDA UDI
    Oticon A/S·05707131162045·ACTO PRO, RITE CBE

    V.A.T.S. CLASSIC CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896088436·V.A.T.S. CLASSIC CLAMP WITHOUT RATCHET CURVED D...

    N/A

    FDA UDI
    Doppkon GmbH & Co. KG·04262494462313·Probe Square Handle Steel D 2.5mm, WL 260mm

    Monoblock Tibial Trial PS Insert

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215042820·

    BIPAP AUTO BIFLEX

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 29, 2025

    CHARTER MEDICAL NEONATAL SYRINGE SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 28, 2025

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·May 8, 2013

    DXTEND STAND PE CUP D38 +6MM

    FDA Adverse Event
    Injury ·3003895575 DEPUY FRANCE·Product code HSD·September 19, 2014

    MOUNTAINEER OC PLATE, SMALL

    FDA Adverse Event
    Injury ·DEPUY SPINE, INC.·Product code KWP·May 18, 2011

    Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·May 13, 2020

    Brilliance iCT Computed Tomography X-ray system, Model 728306

    FDA Enforcement
    Class III ·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016

    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 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

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016

    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

    Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

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