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 ×

    Gemini 2 810+980 Soft Tissue Laser

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

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707185213·AccuFit™ Molar Band UL7 - 35

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551068334·STEALTH sEEG KIT: 2103-34 (QTY 2), 2103-52, 210...

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1103500·Tray, Base, 3.5", Arcamed

    Intacs for Keratoconus, Asymmetric 0.210/0.350 mm

    FDA UDI
    ADDITION TECHNOLOGY, INC.·00850048576162·Intacs Corneal Implants are designed to reshape...

    STA -CALIBRATOR HBPM/LMWH KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    KNEEHAB XP

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·August 30, 2021

    NEUROMONITOR BASIC KIT

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC., MEDOS S.A.·Product code GWM·August 9, 2011

    THERMOPHORE AUTOMATIC HEAT PACK

    FDA Adverse Event
    Malfunction ·BATTLE CREEK EQUIPMENT·Product code IRT·August 8, 2014

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 8, 2013

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 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