1,549 results
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17ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
FDA Enforcement
Class II
·Terminated·Sonogage Inc·September 25, 2013
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 26, 2017
BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·September 17, 2014
Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to use.***Biomet 3i Dental Iberica S.L.*** Biomet 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support prostheses in edentulous or partially edentulous patients. These are intended for use to support single and multiple tooth prostheses.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·March 26, 2014
OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.
FDA Enforcement
Class II
·Terminated·Nidek Inc·August 24, 2016
Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·June 26, 2013
BIOMET 3i Endosseous Dental Implant.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·April 23, 2014
Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90¿ driver in order to retain and drive the screw into the occipital bone.
FDA Enforcement
Class II
·Terminated·Biomet Spine, LLC·September 16, 2015
MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01
FDA Enforcement
Class II
·Completed·Materialise N.V.·July 26, 2023
Biomet Regenerex Primary Taper Cap Item Number 141269
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·October 14, 2020
Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·October 14, 2020
Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
FDA Enforcement
Class II
·Terminated·Biomet Microfixation, LLC·May 24, 2017
Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·October 14, 2020
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis
FDA Enforcement
Class II
·Ongoing·Zimmer, Inc.·November 12, 2025
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis
FDA Enforcement
Class II
·Ongoing·Zimmer, Inc.·November 12, 2025
Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·June 12, 2013
Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder joint as a total shoulder arthroplasty in combination with Zimmer or Biomet s glenoid components, or as a hemi shoulder arthroplasty.
FDA Enforcement
Class II
·Terminated·Zimmer GmbH·October 9, 2019
Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·October 14, 2020
Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·October 31, 2012
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
FDA Enforcement
Class II
·Terminated·Ebi, Llc·November 27, 2013