BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    NeuMoDx CT/NG Assay 2.0

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776387983·Leksell Rongeur 9 1/2" full cvd 5x16mm DA

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776182748·LEKSELL RONGUER, SLIGHT CURVE, BITE

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780183693·Integra® Jarit® Leksell Rongeur, 9-1/4", 5mm Bi...

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464029129·OTICON MORE 1 MINIRITE T C092

    Adler Instrument Company

    FDA UDI
    Adler, Inc.·00810123209729·Brown Tissue Forceps, TW 3mm, OL 254mm(10")

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180188198·LEKSELL BONE RONGEUR; 9", SLIGHT CURVE, 5MM BITE

    devemed

    FDA UDI
    devemed GmbH·04061644030897·Atraumatic tweezers, micro "Cooley" 0.6 mm, ang...

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506088919·LEKSELL RONGEUR 9", SLIGHT CURVE, 5MM BITE

    ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EEG MONITOR WITH BIS, MODEL A-2000

    FDA 510(k)
    FDA Class 2 ·Neurology

    Reicodent

    FDA UDI
    devemed GmbH·04061644038848·Atraumatic tweezers, micro "Cooley" 0.6 mm, ang...

    3DKNEE

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code HSH·November 7, 2008

    UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·September 1, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 16, 2013

    OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025