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

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    AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Redi Splint

    FDA UDI
    FARETEC, INC.·B54112113100·Redi Splint, Large, Olive Drab, flat. Moldable ...

    Luna

    FDA UDI
    ULTRADENT PRODUCTS, INC.·00883205003256·Luna Opal R Mini .018 UL4,5 D/HK (-7°T 0°A)

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551135913·HALO, 1203-5 VEST X-LARGE, ACRYLIC LINER, 1211-...

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707185411·AccuFit™ Molar Band UR7 - 31

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0113100·Decorticating Planer

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 27, 2023

    EXPERIENCE®

    FDA UDI
    Gc Orthodontics America Inc.·D78821131000101·EXPERIENCE Mini ROTH 018/LL1&2-1T 2A

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523183838·3 Hole, 10 mm, Right, 1-Level Anterior Cervical...

    NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BRUX MOUTHGUARDS

    FDA 510(k)
    FDA Unclassified ·Unknown

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 13, 2021

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·October 29, 2014

    TI LCP DISTAL FEMUR PLATE 9 HOLES/236MM-RIGHT

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HRS·August 3, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 8, 2013

    BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·May 21, 2020

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·October 27, 2014

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021