BEUDAMED
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    Filters Classification: Class Ii ×

    Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.

    FDA Enforcement
    Class II ·Terminated·IntroMedic Co., Ltd.·May 9, 2018

    seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.

    FDA Enforcement
    Class II ·Terminated·Genzyme Corporation·June 27, 2012

    seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.

    FDA Enforcement
    Class II ·Terminated·Genzyme Corporation·June 27, 2012

    Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic test for the quantitative determination of iron in human serum and plasma on the Dimension Vista(R) System. Measurements of iron are used in the diagnosis and treatment of diseases such as iron deficiency anemia and other disorders of iron metabolism.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·December 12, 2012

    Bone Dowell Harvest Tubes

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·May 17, 2017

    Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument Kit is used to establish and maintain a port of entry for arthroscopic instruments or for an open procedure. The kit is also used to insert the OsteoSponge¿ SC graft during surgery. Such procedures include, but are not limited to, subchondral bone repair. Affected Part numbers are 6508 and 6511.

    FDA Enforcement
    Class II ·Terminated·Bacterin International, Inc.·April 15, 2015

    The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.

    FDA Enforcement
    Class II ·Terminated·Capso Vision, Inc.·July 15, 2020

    CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.

    FDA Enforcement
    Class II ·Terminated·Capso Vision, Inc.·May 27, 2020

    Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device

    FDA Enforcement
    Class II ·Ongoing·Carefusion 2200 Inc·August 23, 2023

    Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7045; endoscopic surgical device

    FDA Enforcement
    Class II ·Ongoing·Carefusion 2200 Inc·August 23, 2023

    IVEA 500A Intended for Med-Surg patient care.

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·December 21, 2016

    Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Inc·January 29, 2014

    Small Bowel Scope 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 Enforcement
    Class II ·Terminated·Pentax Medical Company·July 6, 2016

    Proteus 235

    FDA Enforcement
    Class II ·Terminated·Ion Beam Applications S.A.·June 28, 2017

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

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 6, 2016

    PICC Tray, STERILE, 12 packs each per case.

    FDA Enforcement
    Class II ·Terminated·Medline Industries, Inc.·September 12, 2018

    Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Inc·January 29, 2014

    Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 6, 2016

    Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 6, 2016

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

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·August 3, 2016