6 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·July 24, 2019
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·November 24, 2021
LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·November 24, 2021
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019
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
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023