2 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthroscopy; 5. regard Item Number: 800772006, OR00977F - OH Total Knee Pack ; 6. regard Item Number: 880403004, OR01009D - Extremity Pack; 7. regard Item Number: 880472001, OR01104A - Basic Pack ; 8. regard Item Number: 880470001, OR01102A - Total Knee ; 9. regard Item Number: 800755006, OR00960F - OH Hip Pack ; 10. regard Item Number: 880471001, OR01103A - Shoulder Arthroscopy ; 11. regard Item Number: 880480001, OR01112A - Hand and Foot ; and 12. regard Item Number: 880468001, OR01100A - Spine.
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·May 3, 2023
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015