BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Dental

    Unity ASC - Down Rod

    FDA UDI
    ENZTEC LIMITED·09421028113052·A reusable surgical instrument intended to be u...

    SRS ENDOSCOPIC STAPLING SYSTEM

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

    DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    FDA Adverse Event
    Malfunction ·QUIDEL CORPORATION·Product code QJR·June 8, 2023

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    FDA Adverse Event
    Malfunction ·QUIDEL CORPORATION·Product code QJR·June 8, 2023

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    FDA Adverse Event
    Malfunction ·QUIDEL CORPORATION·Product code QJR·June 8, 2023

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    FDA Adverse Event
    Malfunction ·QUIDEL CORPORATION·Product code QJR·June 8, 2023

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    FDA Adverse Event
    Malfunction ·QUIDEL CORPORATION·Product code QJR·June 8, 2023

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    FDA Adverse Event
    Malfunction ·QUIDEL CORPORATION·Product code QJR·June 8, 2023

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    FDA Adverse Event
    Malfunction ·QUIDEL CORPORATION·Product code QJR·June 8, 2023

    UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LTJ·September 2, 2011

    ADVANTA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·November 4, 2008

    SELOX ST 60

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVN·July 17, 2013

    HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square; Article Numbers: 21517. 5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5. 7. Locking Stabilization Screw; Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.

    FDA Recall
    Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026

    Allura Xper FD20/15; Catalog numbers: 722058

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square; Article Numbers: 21517. 5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5. 7. Locking Stabilization Screw; Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

    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