BEUDAMED
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    Digital Thermometer, Model T28, T28L

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO: AURORA

    FDA 510(k)
    FDA Class 2 ·Radiology

    OMNI Surgical System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·July 19, 2011

    ZIO ECG UTILIZATION SERVICE

    FDA Adverse Event
    Malfunction ·IRHYTHM TECHNOLOGIES INC.·Product code DQK·September 12, 2014

    M2A 38MMX56MM CUP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 18, 2013

    smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/080; 2) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/090; 3) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect trach tube, Item Number 101/541/070; 4) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect trach tube, Item Number 101/541/080; 5) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect trach tube, Item Number 101/541/090; 6) BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect trach tube, no forceps, Item Number 101/543/070; 7) BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect trach tube, no forceps, Item Number 101/543/080; 8) BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect trach tube, no forceps, Item Number 101/543/090; 9) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect SuctionAid trach tube, Item Number 101/891/070; 10) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect SuctionAid trach tube, Item Number 101/891/080; 11) BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect SuctionAid trach tube, Item Number 101/891/090; 12) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 7.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/070; 13) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/080; 14) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect SuctionAid trach tube (drugs, US ONLY), Item Number 101/892/090; 15) BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/070; 16) BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/080; 17) BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect SuctionAid trach tube, no forceps, Item Number 101/893/090

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 18, 2024

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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