BEUDAMED
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    Filters Classification: Class Ii ×

    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·January 20, 2016

    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·January 20, 2016

    LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES D684-00-0479-01 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) D684-00-0479-02 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (CHINA) D684-00-0479-01C LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)(CHINA) D684-00-0479-02C LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (INDIA) D684-00-0479-07 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) (INDIA) D684-00-0479-08 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (TURKEY) D684-00-0479-09 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0479-10 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, US ONLY D684-00-0479-01U LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, (APA) US ONLY D684-00-0479-02U LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES D684-00-0480-01 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) D684-00-0480-02 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA) D684-00-0480-01C LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(CHINA) D684-00-0480-02C LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (INDIA) D684-00-0480-07 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(INDIA) D684-00-0480-08 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY) D684-00-0480-09 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0480-10 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY D684-00-0480-01U LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, (APA) US ONLY D684-00-0480-02U LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES D684-00-0478-01 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) D684-00-0478-02 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (CHINA) D684-00-0478-01C LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (CHINA) D684-00-0478-02C LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (INDIA) D684-00-0478-07 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (INDIA) D684-00-0478-08 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (TURKEY) D684-00-0478-09 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0478-10 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES, US ONLY D684-00-0478-01U LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) US ONLY D684-00-0478-02U PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 25 cc IABs D884-00-0019-12 PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 34/40 cc IABs D884-00-0019-13

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·August 2, 2023

    MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES D684-00-0295-01 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) D684-00-0295-02 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (W/O STATLOCK) D684-00-0295-03 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA) D684-00-0295-05 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES AND APA (CHINA) D684-00-0295-06 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA D684-00-0295-07 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK (APA) - INDIA D684-00-0295-08 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY) D684-00-0295-09 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) (TURKEY) D684-00-0295-10 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY D684-00-0295-01U MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES APA, US ONLY D684-00-0295-02U MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES D684-00-0294-01 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA) D684-00-0294-02 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (W/O STATLOCK) D684-00-0294-03 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (CHINA) D684-00-0294-05 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES AND APA (CHINA) D684-00-0294-06 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA D684-00-0294-07 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK (APA) INDIA D684-00-0294-08 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (TURKEY) D684-00-0294-09 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA) (TURKEY) D684-00-0294-10 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES, US ONLY D684-00-0294-01U MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES APA, US ONLY D684-00-0294-02U PACKAGED INSERTION KIT - MEGA 7.5 Fr. 30/40 cc IABs D884-00-0019-21

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·August 2, 2023

    SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA) D684-00-0469-01C SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA) D684-00-0469-07 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA) D684-00-0470-01C SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA) D684-00-0470-07 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY) D684-00-0470-09 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES D684-00-0470-01 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY D684-00-0470-01U SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY D684-00-0469-01U SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES D684-00-0469-01 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY D684-00-0469-09 PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs D884-00-0019-16

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·August 2, 2023

    MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 8Fr. 50cc IAB WITH STATLOCK D684-00-0296-01 MEGA 8Fr. 50cc IAB WITH STATLOCK & APA D684-00-0296-02 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (W/O STATLOCK) D684-00-0296-03 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) D684-00-0296-09 MEGA 8Fr. 50cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0296-10 MEGA 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY D684-00-0296-01U MEGA 8Fr. 50cc IAB WITH ACCESSORIES, (APA) US ONLY D684-00-0296-02U MEGA 8Fr. 50cc IAB WITH ACCESSORIES (CHINA) D684-00-0498-01 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (INDIA) D684-00-0498-07 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (APA) (INDIA) D684-00-0498-08 PACKAGED INSERTION KIT - MEGA 8 Fr. 50 cc IAB D884-00-0019-17

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·August 2, 2023

    SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES D684-00-0576-01 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE D684-00-0576-03 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE D684-00-0576-05 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) D684-00-0576-09 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY D684-00-0576-01U PACKAGED INSERTION KIT - SENSATION PLUS 8 Fr. 50 cc IAB D884-00-0019-23

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·August 2, 2023

    TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES D684-00-0545-01 TRANS-RAY 7FR. 40cc IAB WITH ACCESSORIES D684-00-0546-01 TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES D684-00-0607 TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES D684-00-0608 PACKAGED INSERTION KIT - TRANS-RAY 7 Fr. 34/40 cc IABs D884-00-0019-18 PACKAGED INSERTION KIT - TRANS-RAY PLUS 7.5 Fr. 35/40 IABs D884-00-0019-26

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·August 2, 2023

    YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description Part Number YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0559-01 YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0559-02 YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0560-01 YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0560-02 YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0561-01 YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0561-02 PACKAGED INSERTION KIT - YAMATO PLUS-R 7.5 Fr. 30/35/40 cc IABs D886-00-0019-25

    FDA Enforcement
    Class II ·Ongoing·Datascope Corp.·August 2, 2023

    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 17, 2013

    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·April 17, 2013

    Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·March 18, 2015

    Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures

    FDA Enforcement
    Class II ·Terminated·B. Braun Medical, Inc.·December 7, 2016

    Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

    FDA Enforcement
    Class II ·Ongoing·Datascope Corporation·September 2, 2020

    Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

    FDA Enforcement
    Class II ·Ongoing·Datascope Corporation·September 2, 2020

    Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01

    FDA Enforcement
    Class II ·Ongoing·Datascope Corporation·September 2, 2020

    Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

    FDA Enforcement
    Class II ·Ongoing·Datascope Corporation·September 2, 2020

    Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

    FDA Enforcement
    Class II ·Ongoing·Datascope Corporation·September 2, 2020

    Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

    FDA Enforcement
    Class II ·Ongoing·Datascope Corporation·September 2, 2020

    Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.

    FDA Enforcement
    Class II ·Ongoing·Datascope Corporation·September 2, 2020