BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MoCo Insert

    FDA UDI
    Noras MRI products GmbH·04251269206726·Collision indicator for transfer during intraop...

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1204350·

    ZAVATION

    FDA UDI
    Zavation LLC·00842166188075·Custom Tap Posterior Cervical

    WOUND PROTECTOR/RETRACTOR

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

    AMEDA PLATINUM BREAST PUMP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 26, 2026

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 20, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014

    BARD FLAT MESH

    FDA Adverse Event
    Injury ·DAVOL INC.·Product code FTL·June 3, 2011

    ACT ARTIC HD ARCOM XL 28X44MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·December 27, 2017

    G7 DUAL MOBILITY LINER 44MM F

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·December 27, 2017

    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

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021