BEUDAMED
    18 results · 25ms · Sources: EU EUDAMED, US FDA

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    WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE

    FDA 510(k)
    FDA Class 2 ·Radiology

    A Series Heated Humidifier

    FDA UDI
    Respironics, Inc.·00606959032064·BiPAP A Series, System One Heated Humidifier, J...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540139177·RAMUS RETRACTOR, DAUTREY

    Sklar

    FDA UDI
    SKLAR CORPORATION·10649111159183·HOPKINS PLASTER KNIFE 7 3/4 INCHES

    OSI O-BALL ABUTMENT HEAD IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PRECISION SPECTRA

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 9, 2017

    S3 EX - 3005

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 14, 2013

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 13, 2011

    EXTRACTOR RX RETRIEVAL BALLOON

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code FGE·August 13, 2008

    3.5MM LCP SUPERIOR CLAVICLE PLATE/7 HOLE/RIGHT/100MM

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HRS·August 15, 2017

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 4, 2016

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 4, 2016

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·May 4, 2016

    TFNA FEM NAIL Ø11 R 130° L360 TIMO15

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HSB·February 23, 2023

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·April 5, 2018

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

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