BEUDAMED
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    NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337

    FDA 510(k)
    FDA Class 2 ·Radiology

    REBOUND HRD

    FDA Adverse Event
    Malfunction ·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011

    BCC GAMMA CAMERA

    FDA 510(k)
    FDA Class 2 ·Radiology

    REVEAL PLUS INSERTABLE LOOP RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STYLE 68 SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·November 19, 2020

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2025

    5MM, 33CM PEEK MONOPOLAR HANDLE 33CM

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code KOG·April 29, 2013

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·May 10, 2011

    FREESTYLE LITE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 22, 2008

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024