BEUDAMED
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    ACCUTECH ENDOLITE PROBE

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

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00610251·

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70610251·Mini Sprint-Brackets 5-5 Roth .022" 1000 Bracke...

    FORTAFLEX SURGICAL MESH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LIFECARD CF COMPACT RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARE ASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·March 26, 2013

    HEARTSTREAM XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 12, 2008

    ENTERALITE INFINITY ENTERAL FEEDING PUMP

    FDA Adverse Event
    Other ·MOOG MEDICAL DEVICES GROUP·Product code LZH·April 4, 2011

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012