BEUDAMED
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    Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM 189442 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189440 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189426 Vanguard Knee System, PS Mono Lock Tibial Bearing, 16 MM X 63 MM 189440 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·June 3, 2020

    Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4 154339 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D7 154355 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, B3 154361 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, C4 154366 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, D4 154370 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, E3 154375 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F3 154375 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F3 154376 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F4 154376 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F4 154377 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Right, Cemented, F5 159575 Oxford Partial Knee System Anatomic Meniscal Bearing, Right Medial, Medium, 3 MM Product Usage: Knee prosthesis

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·June 3, 2020

    Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D5 US154725 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6 US154705 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B6 US154707 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B7 US154713 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C5 US154719 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C8 US154720 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D4 US154721 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D4 US154723 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D5 US154725 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6 US154727 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D7 US154727 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D7 US154731 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, E4 US154735 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, E6 US154745 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, A6 US154745 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, A6 US154746 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, A7 US154711 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C4 US154734 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, E6 US154730 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, E4 US154711 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C4 Product Usage: Knee prosthesis

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·June 3, 2020

    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

    Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 3, 2026