BEUDAMED
    103 results · 16ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Terminated × Clear all

    SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***PIG***Max. 1200 psi (8274 kPa)***Markers***Open End 6 Sideholes***Angiographic Catheter*** REF Cat No.***Lot***Use By***Assembled in Mexico Cordis Corporation, 14201 NW 60th Ave. Miami Lakes, Florida 33014, USA***EC***REP*** Cordis Cashel, Cahir Road Cashel, Co Tipperary, Ireland***Cordis***a Johnson&Johnson company***" UPN H739532598A3, Cat No 532-598A, No. MB 10, French Size 5, Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6. UPN H739532598B3, Cat No 532-598B, No. MB 20, French Size 5, Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6. UPN H73953298C3, Cat No 532-598C, No MB 20 French Size 5, Shape (PIG), Length, cm 65, Flow Rate, ml/sec, 30, Side Holes 6. UPN H73953298D3, Cat No 532-598D, No MB 2 French Size 5, Shape (PIG), Length , cm 70, Flow Rate, ml/sec, 30, Side Holes 10. Cordis SUPER TORQUE MB angiographic catheters with Market Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.

    FDA Recall
    Terminated ·Cordis Corporation·Product code DQO·November 21, 2011

    Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-302. 6F MULTI PIG 155 (5-pack). Distal curve FL4, FR4, PIG 155. 100 and 110 cm length. Made in Mexico: Parque industrial Le Mesa, Tijuana, Baja California 22050 MEX. Boston Scientific Corporation, Natick, MA 01760-1537 USA.

    FDA Recall
    Terminated ·Boston Scientific·Product code DQO·November 20, 2007

    Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C

    FDA Recall
    Terminated ·Cordis Corporation·Product code DQO·July 21, 2021

    Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B

    FDA Recall
    Terminated ·Cordis Corporation·Product code DQO·July 21, 2021

    Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A

    FDA Recall
    Terminated ·Cordis Corporation·Product code DQO·July 21, 2021

    Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB

    FDA Recall
    Terminated ·Cordis Corporation·Product code DQO·July 21, 2021

    Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQO·May 5, 2010

    Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 7.5Fr/15cm, C-UDLMY-751J-190-PIG-ABRM-FST-A, G30102, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Double lumen Polyurethane, 7.5Fr/20cm, C-UDLMY-751J-190-PIG-RSC-ABRM-FST-A, G30088, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, 7.0 Fr/ 15cm, C-UTLMY-701J-190-PIG-ABRM-FST-A-RD, G47845, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Spectrum Central Venous Tray, Minocycline/Rifampin Impregnated Triple Lumen Polyurethane, 7.0 Fr/ 20cm, C-UTLMY-701J-190-PIG-RSC-ABRM-FST-A-RD, G47846, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

    FDA Recall
    Terminated ·Cook, Inc.·Product code FOZ·October 4, 2010

    Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-301. 6F MULTI PIT 124 (Single Pack). Distal Curve FL4, FR4, PIG 145. 100 and 110 cm Length. Made in Mexico: Parque industrial Le Mesa, Tijuana, Baja California 22050 MEX. Boston Scientific Corporation, Natick, MA 01760-1537 USA.

    FDA Recall
    Terminated ·Boston Scientific·Product code DQO·November 20, 2007

    Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·December 19, 2013

    GEMINI TF Big Bore computer tomograph software version 3.6. Catalog #882476, Gantry S/N 9001-9023. The GEMINI TF Big Bore is a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·August 5, 2009

    Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 30, 2013

    GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·December 5, 2013

    Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·December 4, 2013

    Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·October 24, 2012

    Brilliance Big Bore CT (Computed Tomography) System, 510 (k) #K033357, Model #728243, Serial Numbers: 7006, 7154, and 7349. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Product Usage: The Brilliance Big Bore is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at difference angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 29, 2011

    The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·September 27, 2007