33 results
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19ms
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Sources: EU EUDAMED, US FDA
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 11, 2019
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 11, 2019
Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used to correct leg length, or rotational discrepancies in the femur.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 26, 2014
Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 26, 2014
Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 26, 2014
C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only ¿5.0GH 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch.
FDA Enforcement
Class II
·Terminated·Camlog Usa·September 25, 2013
Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks.
FDA Enforcement
Class II
·Terminated·Talladium Inc·September 16, 2020
SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.
FDA Enforcement
Class II
·Terminated·Sam Medical Products·November 5, 2014
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
FDA Enforcement
Class II
·Terminated·Sam Medical Products·March 23, 2022
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686282EN
FDA Enforcement
Class II
·Terminated·Ivoclar Vivadent AG·May 13, 2020
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686194
FDA Enforcement
Class II
·Terminated·Ivoclar Vivadent AG·May 13, 2020
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/CAM technology Product Number: 686193
FDA Enforcement
Class II
·Terminated·Ivoclar Vivadent AG·May 13, 2020
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
FDA Enforcement
Class II
·Terminated·Medtronic Xomed, Inc.·October 2, 2013
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686195
FDA Enforcement
Class II
·Terminated·Ivoclar Vivadent AG·May 13, 2020
Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·March 20, 2013
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.
FDA Enforcement
Class III
·Terminated·Tosoh Bioscience Inc·August 22, 2018
The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02R monitor measures and displays oxygen partial pressure and temperature in tissue.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·May 27, 2015
The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02 monitor measures and displays oxygen partial pressure (Pt02) and temperature in brain tissue.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·May 27, 2015
Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includes a radiologic / urologic treatment table, maybe used for urological treatment, planning and diagnostic procedures, including but not limited to.
FDA Enforcement
Class II
·Terminated·Hans Pausch Rontgengeratebau Gmbh·June 7, 2017
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
FDA Enforcement
Class I
·Terminated·STEP-HAR MEDICAL LLC·May 19, 2021