BEUDAMED
    21 results · 21ms · Sources: EU EUDAMED, US FDA

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    WEXLER VASCULAR CLAMP SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06945664823494·Reusable SpO2 Sensor/Palco/Finger Clip/Pediatri...

    Leva® Anterior Interbody System

    FDA UDI
    Spine Wave, Inc.·10840642108736·Modular Spacer, 34 mm (W) x 30 mm (L) x 19 mm (...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450320785·

    Stage-1

    FDA UDI
    KEYSTONE DENTAL, INC.·D768S11014816K0·Drill

    Stage-1

    FDA UDI
    KEYSTONE DENTAL, INC.·D768S11014810K0·Drill

    4.8 x 230 mm Surgibit Drill

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215055127·The saleable unit (device count) is 1, there ar...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197410991·Corwin Scalpel Handle, round 150mm,...

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·May 9, 2002

    SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ENA SCREEN EIA KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·August 2, 2021

    K-WIRE

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HWC·December 9, 2016

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·May 13, 2013

    TRUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 11, 2014

    AFFINITY BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code HDD·May 19, 2011

    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    FDA Enforcement
    Class II ·Terminated·Oscor, Inc.·December 28, 2016

    Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115V, 100V, and 230/240V), 510 (k) #K101148, Serial Numbers: 994-1350001 through 104-1356894. The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to ... a blanket that is placed over or around adult, pediatric or neonatal patients in order to warm them. The heated air is blown through a connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air. The system can be used in long-term care facilities, surgical facilities, hospitals including the Post-anesthesia Care Unit (PACU), Intensive Care Unit (ICU), Surgical Intensive Care Unit (SICU), Emergency Room (ER), Operating Room (OR), medical and surgical floors, or any other department or hospital facility requiring patient temperature management. To prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. Used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air heated blanket.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products Inc·Product code DWJ·July 20, 2011

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·January 24, 2024