BEUDAMED
    16 results · 27ms · Sources: EU EUDAMED, US FDA

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    MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776305376·Leksell Rongeur 9 12" full cvd 3x16mm DA

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780382799·Integra® Jarit® Leksell Rongeur, 9-1/4", 3mm Bi...

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    Adler Instrument Company

    FDA UDI
    Adler, Inc.·00810123201235·BROWN TISS FCPS 6"

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361036272·SCREW, SOLID WALL, CANNULATED, Ø12MM X 65MM, SA...

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506088896·LEKSELL RONGEUR 9", SLIGHT CURVE, 3MM BITE

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 12, 2021

    CONTOUR NEXT EZ BLOOD GLUCOSE METER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 31, 2019

    UNK

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

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - BUFFALO GROVE·Product code FRN·September 1, 2011

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·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