241 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001; Product is manufactured and distributed by Medtronic Vascular, Santa Rosa, CA 95403
FDA Recall
Terminated
·Medtronic Vascular·Product code ITX·November 1, 2006
CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
FDA Recall
Terminated
·Civco Medical Instruments Co. Inc.·Product code ITX·October 21, 2015
Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576
FDA Recall
Terminated
·Exact Medical Manufacturing, Inc.·Product code ITX·April 29, 2021
Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies
FDA Recall
Terminated
·Philips Ultrasound Inc·Product code ITX·August 30, 2019
Intraoperative Ultrasound Cover Kit
FDA Recall
Terminated
·Bard Access Systems, Inc·Product code ITX·November 3, 2004
Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W.
FDA Recall
Terminated
·Hitachi Medical Systems America Inc·Product code ITX·May 7, 2004
EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC6, Software Versions: V11-01, V11-03, V12-03 and V12-04A.
FDA Recall
Terminated
·Hitachi Medical Systems America Inc·Product code ITX·May 12, 2008
CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. The firm name on the label is CIVCO, Kalona, IA.
FDA Recall
Terminated
·Civco Medical Instruments Inc·Product code ITX·January 21, 2011
CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers ((5) for use with SonoSite L25 series transducers, 18 GAUGE, Rx.
FDA Recall
Terminated
·CIVCO Medical Instruments Co., Inc.·Product code ITX·November 2, 2018
Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code ITX·October 16, 2020
EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A.
FDA Recall
Terminated
·Hitachi Medical Systems America Inc·Product code ITX·May 12, 2008
ACUSON X300, X300 PE and SONOVISTA X300 (all versions) with cardiovascular options installed; ACUSON X300: 10037409, 10132987, 10038837; SONOVISTA X300: 10133170; ACUSON X300 PE: 10348531, 10348532, 10348533; X300 Cardiovascular Options: 10133037, 10348777, 10349032, 10427797, 10427822, 10427816, 10563788; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc., Mountain View, CA
1230 Shorebird Way
P.O. Box 7393
Mountain View CA 94043·Product code ITX·August 17, 2010
CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5 depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 18 GAUGE, Rx.
FDA Recall
Terminated
·CIVCO Medical Instruments Co., Inc.·Product code ITX·November 2, 2018
CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx.
FDA Recall
Terminated
·CIVCO Medical Instruments Co., Inc.·Product code ITX·November 2, 2018
BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively.
FDA Recall
Terminated
·Verathon, Inc.·Product code ITX·September 29, 2020
Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17
FDA Recall
Terminated
·Exact Medical Manufacturing, Inc.·Product code ITX·April 29, 2021
Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
FDA Recall
Terminated
·Exact Medical Manufacturing, Inc.·Product code ITX·April 29, 2021
Probe Cover, 6" x 96", PE, w 3 elastic bands- Ultrasonic Transducer Cover Item ID: E6443N
FDA Recall
Terminated
·Exact Medical Manufacturing, Inc.·Product code ITX·April 29, 2021
IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical
FDA Recall
Terminated
·Lumenis, Inc.·Product code ITX·October 14, 2021
SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Mfg for:
FDA Recall
Terminated
·CIVCO Medical Instruments Co., Inc.·Product code ITX·November 2, 2018