6 results
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7ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·October 7, 2015
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017
Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 30-0023-S 30.0mm Acutrak 2¿ - 5.5 Screw 30-0025 35.0mm Acutrak 2¿ - 5.5 Screw 30-0025-S 35.0mm Acutrak 2¿ - 5.5 Screw 30-0027 40.0mm Acutrak 2¿ - 5.5 Screw 30-0027-S 40.0mm Acutrak 2¿ - 5.5 Screw 30-0029 45.0mm Acutrak 2¿ - 5.5 Screw 30-0029-S 45.0mm Acutrak 2¿ - 5.5 Screw 30-0031 50.0mm Acutrak 2¿ - 5.5 Screw 30-0031-S 50.0mm Acutrak 2¿ - 5.5 Screw 30-0084 55.0mm Acutrak 2¿ - 5.5 Screw 30-0084-S 55.0mm Acutrak 2¿ - 5.5 Screw 30-0085 60.0mm Acutrak 2¿ - 5.5 Screw 30-0085-S 60.0mm Acutrak 2¿ - 5.5 Screw 30-0620 20.0mm Acutrak 2¿ - 4.7 Screw 30-0620-S 20.0mm Acutrak 2¿ - 4.7 Screw 30-0622 22.0mm Acutrak 2¿ - 4.7 Screw 30-0622-S 22.0mm Acutrak 2¿ - 4.7 Screw 30-0624 24.0mm Acutrak 2¿ - 4.7 Screw 30-0624-S 24.0mm Acutrak 2¿ - 4.7 Screw 30-0626 26.0mm Acutrak 2¿ - 4.7 Screw 30-0626-S 26.0mm Acutrak 2¿ - 4.7 Screw 30-0628 28.0mm Acutrak 2¿ - 4.7 Screw 30-0628-S 28.0mm Acutrak 2¿ - 4.7 Screw 30-0630 30.0mm Acutrak 2¿ - 4.7 Screw 30-0630-S 30.0mm Acutrak 2¿ - 4.7 Screw 30-0635 35.0mm Acutrak 2¿ - 4.7 Screw 30-0635-S 35.0mm Acutrak 2¿ - 4.7 Screw 30-0640 40.0mm Acutrak 2¿ - 4.7 Screw 30-0640-S 40.0mm Acutrak 2¿ - 4.7 Screw 30-0645 45.0mm Acutrak 2¿ - 4.7 Screw 30-0645-S 45.0mm Acutrak 2¿ - 4.7 Screw 30-0650 50.0mm Acutrak 2¿ - 4.7 Screw 30-0650-S 50.0mm Acutrak 2¿ - 4.7 Screw 30-0740 40.0mm Acutrak 2¿ - 7.5 Screw 30-0740-S 40.0mm Acutrak 2¿ - 7.5 Screw 30-0745 45.0mm Acutrak 2¿ - 7.5 Screw 30-0745-S 45.0mm Acutrak 2¿ - 7.5 Screw 30-0750 50.0mm Acutrak 2¿ - 7.5 Screw 30-0750-S 50.0mm Acutrak 2¿ - 7.5 Screw 30-0755 55.0mm Acutrak 2¿ - 7.5 Screw 30-0755-S 55.0mm Acutrak 2¿ - 7.5 Screw 30-0760 60.0mm Acutrak 2¿ - 7.5 Screw 30-0760-S 60.0mm Acutrak 2¿ - 7.5 Screw 30-0770 70.0mm Acutrak 2¿ - 7.5 Screw 30-0770-S 70.0mm Acutrak 2¿ - 7.5 Screw 30-0775 75.0mm Acutrak 2¿ - 7.5 Screw 30-0775-S 75.0mm Acutrak 2¿ - 7.5 Screw 30-0780 80.0mm Acutrak 2¿ - 7.5 Screw 30-0780-S 80.0mm Acutrak 2¿ - 7.5 Screw 30-0785 85.0mm Acutrak 2¿ - 7.5 Screw 30-0785-S 85.0mm Acutrak 2¿ - 7.5 Screw 30-0790 90.0mm Acutrak 2¿ - 7.5 Screw 30-0790-S 90.0mm Acutrak 2¿ - 7.5 Screw 30-0795 95.0mm Acutrak 2¿ - 7.5 Screw 30-0795-S 95.0mm Acutrak 2¿ - 7.5 Screw 30-0800 100.0mm Acutrak 2¿ - 7.5 Screw 30-0800-S 100.0mm Acutrak 2¿ - 7.5 Screw 30-0805 105.0mm Acutrak 2¿ - 7.5 Screw 30-0805-S 105.0mm Acutrak 2¿ - 7.5 Screw 30-0810 110.0mm Acutrak 2¿ - 7.5 Screw 30-0810-S 110.0mm Acutrak 2¿ - 7.5 Screw 30-0815 115.0mm Acutrak 2¿ - 7.5 Screw 30-0815-S 115.0mm Acutrak 2¿ - 7.5 Screw 30-0820 120.0mm Acutrak 2¿ - 7.5 Screw Micro Acutrak 2 Part Number/Part Description: AT2-C08 through AT2-S34-S 8.0-34.0mm, Micro Acutrak 2¿ Bone Screw
FDA Enforcement
Class II
·Ongoing·Acumed LLC·January 4, 2023