40 results
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11ms
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Sources: EU EUDAMED, US FDA
Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155330 Knees AGC Knee System PS Molded Tibial Component, 14 MM X 70 MM 155344 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 75 MM 155346 Knees AGC Knee System PS Molded Tibial Component, 12 MM X 75 MM 155326 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 70 MM 155328 Knees AGC Knee System PS Molded Tibial Component, 12 MM X 70 MM 155388 Knees AGC Knee System PS Molded Tibial component, 18 MM X 85 MM Product Usage: Knee prosthesis
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·June 3, 2020
AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 21, 2018
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·February 21, 2018
CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
FDA Enforcement
Class II
·Terminated·Graphic Controls Acquisition Corporation·April 20, 2022
CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
FDA Enforcement
Class II
·Terminated·Graphic Controls Acquisition Corporation·April 20, 2022
CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
FDA Enforcement
Class II
·Terminated·Graphic Controls Acquisition Corporation·April 20, 2022
CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US
FDA Enforcement
Class II
·Terminated·Graphic Controls Acquisition Corporation·April 20, 2022
CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
FDA Enforcement
Class II
·Terminated·Graphic Controls Acquisition Corporation·April 20, 2022
CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
FDA Enforcement
Class II
·Terminated·Graphic Controls Acquisition Corporation·April 20, 2022
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fetal), cardiac pediatric, cerebral vascular, cephalic (adult), cephalic (neonatal), fetal/obstetric, gynecological, intraoperative (vascular), intraoperative (cardiac), musculoskeletal (conventional), musculoskeletal (superficial), other: urology, pediatric, peripheral vessel, small organ (breast, thyroid, testicle), transesophageal (cardiac), trans rectal, transvaginal.
FDA Enforcement
Class II
·Terminated·Philips Ultrasound, Inc.·April 20, 2016
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
EasyDiagnost Eleva DRF (Stitching Patient Support) 706032
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost Single Detector (Stitching Patient Support) 712020
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
CombiDiagnost R90 (Stitching Patient Support) 709030
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018
DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018