BEUDAMED
    21 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 ×

    EXCELLAGEN

    FDA 510(k)
    FDA Unclassified ·Unknown

    Bone cutters

    FDA UDI
    DFS - DIAMON GmbH·04057176162793·Bone cutter FG L 1,6 mm, pu: 1 St.

    N/A

    FDA UDI
    Smith & Nephew, Inc.·03596010034953·HIBBS OSTEOTOME STRAIGHT 28.5MM

    ADVIA Centaur® Multi-Diluent 7

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414175270·Multidil 7 (2PK) - CENTAUR - CAL - 2x5mL

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306815935·Volkman 6 Prong Retractor, Sharp, 21.5cm

    RAGNELL SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896075436·RAGNELL SCISSORS UNDER MINING SPATULATED CURVED...

    CoolBreeze

    FDA UDI
    GENESIS BIOSYSTEMS, INC.·00818257020081·Cool Breeze LED wand - Blue

    CoolBreeze

    FDA UDI
    GENESIS BIOSYSTEMS, INC.·00818257020074·Cool Breeze LED Wand - Red

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973100461·Poly Insert CR, Size 3, 18mm

    PRIMA OXYGEN MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NANOKNIFE SINGLE ELECTRODE PROBE, 15 CM

    FDA Adverse Event
    Injury ·ANGIODYNAMICS·Product code GEI·March 12, 2012

    EXPRESSEW III W/HOOK

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code LXH·January 16, 2020

    RESTORELLE  Y

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code OTO·July 14, 2021

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

    ANGLED ACET INSERTR

    FDA Adverse Event
    Malfunction ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LXH·September 23, 2014

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 20, 2011

    Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    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