BEUDAMED
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    FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code OFT·July 10, 2019

    FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160

    FDA Enforcement
    Class II ·Terminated·B. Braun Medical, Inc.·September 11, 2019

    Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.

    FDA Enforcement
    Class II ·Terminated·Stanbio Laboratory, LP·September 5, 2018

    Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.

    FDA Recall
    Terminated ·Product code GKR·February 8, 2018

    Matrix MAX3 Actuator, Catalog Number: MAX30 A300545A2510V000, SKF USA, Inc. Norristown, PA 19403

    FDA Recall
    Terminated ·Skf USA Inc·July 24, 2007

    Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000, SKF USA, Inc. Norristown, PA 19403

    FDA Recall
    Terminated ·Skf USA Inc·July 24, 2007

    Matrix MAX3 Actuator, Catalog Number : MAX30 A300545A252L0V000, SKF USA, Inc. Norristown, PA 19403

    FDA Recall
    Terminated ·Skf USA Inc·July 24, 2007

    Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code FDF·April 6, 2016

    COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc.·Product code FFF·December 18, 2018

    COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc.·Product code FFF·December 18, 2018

    Pentax Video Colonoscope Model: EC34-i10L

    FDA Recall
    Terminated ·Pentax of America Inc·Product code FDF·January 3, 2020

    Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.

    FDA Recall
    Terminated ·Pentax of America Inc·Product code FDF·August 15, 2016

    Obturator (shortcone), Part number 26114 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (e22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.

    FDA Recall
    Terminated ·Medrobotics Corporation·Product code FDF·January 25, 2019

    Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 40 UPN Number: M00513332 REF: 1333-40

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FFF·August 28, 2007

    Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code FDF·April 6, 2016

    Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes.

    FDA Recall
    Terminated ·Fujinon Inc·Product code FDF·March 27, 2006

    Boston Scientific Radial Jaw Large Capacity Biopsy Forceps, Sterile, 240 mm. Box of 20 U PN Number: M00513321 REF: 1332-20

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FFF·August 28, 2007

    Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FDF·October 16, 2020

    Colonovideoscope Model CF-H180AL

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FDF·April 22, 2022

    Pentax Video Colonoscope Model: EC38-i10L

    FDA Recall
    Terminated ·Pentax of America Inc·Product code FDF·January 3, 2020