BEUDAMED
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    ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Bard® Linton Intragastric Tube

    FDA UDI
    C. R. Bard, Inc.·00801741076848·Bard® Linton Intragastric Tube

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·October 26, 2017

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·October 26, 2017

    BD BLUNT FILL NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON·Product code GAA·December 22, 2025

    TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLEARFIL AP-X

    FDA 510(k)
    FDA Class 2 ·Dental

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·March 6, 2019

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·August 24, 2016

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·May 10, 2016

    Bard Single Intragastric Linton Balloon Tube, REF: 0092740

    FDA Recall
    Open, Classified ·C.R. Bard Inc·Product code KNT·April 17, 2025

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DQX·May 3, 2013

    FX OXY W/HR & ART FILTER

    FDA Adverse Event
    Malfunction ·TERUMO CORP, ASHITAKA·Product code DTZ·August 20, 2014

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·May 10, 2011

    EVOLUT FX DCS

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 24, 2025

    Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740

    FDA Enforcement
    Class I ·Ongoing·C.R. Bard Inc·May 28, 2025

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code ITX·November 10, 2022

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024