BEUDAMED
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    IMIX PANORAD AND SOMARAD

    FDA 510(k)
    FDA Class 2 ·Radiology

    Bur PM2-70 80K FC Ø0.5x80 St

    FDA UDI
    Bien-Air Surgery SA·17630055519778·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X1014350·10mm H x 14mm W x 35mm L x 0 degrees XLIF

    MAGNIFIER LENS

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111628·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741014350·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L101435120·10mm H x 14mm W x 35mm L XLIF Trial 12 degree L...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X101435120·10mm H x 14mm W x 35mm W x 12 degrees XLIF

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674101435060·

    QUADRA H FEMORAL STEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·January 14, 2011

    EQUIVABONE

    FDA Adverse Event
    Malfunction ·ETEX CORP.·Product code MQV·April 18, 2014

    VIKING OPTIMA GUIDING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM

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

    X SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 29, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 25, 2011

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Death ·HEARTWARE, INC.·Product code DSQ·April 3, 2026

    CPS TIB SPINDLE LT 12X37X42MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·September 16, 2019

    UNK COIL-THERMO MECHANICAL

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 18, 2020

    Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·January 30, 2013

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025