BEUDAMED
    16 results · 22ms · 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 ×

    Mini PCNL-System

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

    Pantheon PFR System

    FDA UDI
    ADLER ORTHO SPA·08050880237975·Pantheon Salvage Plate with Spikes Compression ...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694045063·SmartFlex Sterilization Tray

    METZENBAUM SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896055629·METZENBAUM SCISSORS CURVED TENOTOMY TIP BLADES ...

    POSNICK MAXILLARY EXPANDING FORCEPS, 205 MM

    FDA UDI
    W.H. Holden, Inc.·D9282007700·

    PROVIEW MEDICAL IMAGE DISPLAY MODULE

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARx Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·February 19, 2008

    RAD-G

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·October 17, 2024

    ERBE APC 2

    FDA Adverse Event
    Injury ·ERBE ELEKTROMEDIZIN GMBH·Product code GEI·July 28, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014

    CUB PEDIATRIC CRIB- FIXED BASE

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FMS·July 1, 2013

    ABSOLUTE .035 SELF EXPANDING STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code FGE·May 23, 2008

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021