3 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 35 mm, P/N 7211121, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code HWC·August 21, 2007
Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021
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