BEUDAMED
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    Orchid Safety Release Valve

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776306656·Leksell Rongeur 9 12" full cvd 8x16mm DA

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780183686·Integra® Jarit® Leksell Rongeur, 9-1/4", 8mm Bi...

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464029112·OTICON MORE 1 MINIRITE T C090

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506088902·LEKSELL RONGEUR 9", SLIGHT CURVE, 8MM BITE

    devemed

    FDA UDI
    devemed GmbH·04061644030880·Atraumatic tweezers, micro "Cooley" 0.6 mm, str...

    ENDOWRIST ONE VESSEL SEALER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    Reicodent

    FDA UDI
    devemed GmbH·04061644038534·Atraumatic tweezers, micro "Cooley" 0.6 mm, str...

    FMP METAL-ON-METAL

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

    ASR UNI FEMORAL IMPL SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 1, 2011

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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