BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    RENAISSANCE

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743717·ACHIMED ACHILLES SUPP SAND II

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05056139249174·UNITY KNEE™ PS-C INSERT - Size 8 x 12mm

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321208120·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167311208120·

    MiniSPC Button

    FDA UDI
    APPLIED MEDICAL TECHNOLOGY, INC.·00842071152130·12F x 0.8cm MiniSPC Low Profile Suprapubic Cath...

    ULTICARE DISPOSABLE PEN NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GAMMA-BSM; BETA-BSM; EQUIVABONE

    FDA 510(k)
    FDA Class 2 ·Dental

    WAVEWRITER ALPHA? PRIME

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 15, 2025

    15X100MM KII OPTICAL ACCESS SYSTEM NON-THREADED

    FDA Adverse Event
    Other ·APPLIED MEDICAL·Product code GCJ·July 26, 2011

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 20, 2013

    SYNCHRON® LXI® 725 CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 10, 2011

    PULSE GEN MODEL 101

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·August 15, 2008

    STAPLE, IMPLANTABLE

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 9, 2017

    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018