BEUDAMED
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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    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

    Spectrum IQ Infusion Pump, Product Code 3570009

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·September 3, 2025

    Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - ARDEQT269000C, BRAINLAB CAMERA - ARDEQT269001A, BRAINLAB CAMERA - ARDEQT269001C, BRAINLAB CAMERA - ARDEQT269004A, BRAINLAB CAMERA - ARDEQT269004C, BRAINLAB CAMERA - ARDEQT269005A, BRAINLAB CAMERA - ARDEQT269005C, EQTBRB SAT12 - ARDSAT269000A, EQTBRB SAT13 - ARDSAT269001A, EQTFHS010 11 - ARDEQT239014A, EQTFHS010 SAT12 - ARDSAT239005A, EQTFHS010 SAT13 - ARDSAT239006A, EQTFHS010 SAT16 - ARDSAT239023A, EQTMHD231 - ARDEQT239013A, EQTMHD231 11 - ARDEQT239016A, EQTMHD231 16 - ARDEQT239023A, EQTMHD231 SAT12 - ARDSAT239013A, EQTMHD231 SAT13 - ARDSAT239014A, EQTMHS013 08 - ARD2EQT00010A, EQTMHS013 11 - ARDEQT239007A, EQTMHS013 14 - ARDEQT239008A, EQTMHS013 16 - ARDEQT239009A, EQTMHS013 SAT12 - ARDSAT239007A, EQTMHS013 SAT13 - ARDSAT239008A, EQTMHS021 11 - ARDEQT239010A, EQTMHS021 14 - ARDEQT239011A, EQTMHS021 16 - ARDEQT239012A, EQTMHS021 SAT12 - ARDSAT239009A, EQTMHS021 SAT13 - ARDSAT239010A, EQTSC07 SAT12 - ARD515031140A, EQTSC07 SAT13 - ARD515032140A, EQTSC07 SAT16 - ARD2SAT00120A, EQTSC07 SAT16 - ARDSAT229007A, EQTSHD 11 - ARDEQT229001A, EQTSHD SAT - ARD515031990A, EQTSHD SAT - ARD515032990A, EQTSPC12 08 - ARDEQT269008A, EQTSPC12 11 - ARDEQT269009A, EQTSPC12 SAT12 - ARDSAT269005A, EQTSPC12 SAT13 - ARDSAT269006A, EQTXHD127 08 - ARDEQT239026A, EQTXHD127 11 - ARDEQT239027A, EQTXHD127 16 - ARDEQT239028A, EQTXHD127 SAT12 - ARDSAT239021A, EQTXHD127 SAT13 - ARDSAT239022A, EQTXHS010 08 - ARD2EQT00030A, EQTXHS010 08 - ARDEQT239024A, EQTXHS010 10 - ARD2EQT00050A, EQTXHS010 11 - ARDEQT239017A, EQTXHS010 14 - ARDEQT239019A, EQTXHS010 16 - ARDEQT239020A, EQTXHS010 SAT12 - ARDSAT239015A, EQTXHS010 SAT13 - ARDSAT239018A, EQTXHS021 08 - ARDEQT239025A, EQTXHS021 11 - ARDEQT239018A, EQTXHS021 14 - ARDEQT239021A, EQTXHS021 16 - ARDEQT239022A, EQTXHS021 SAT12 - ARDSAT239019A, EQTXHS021 SAT13 - ARDSAT239020A, EQTXS3216 11 - ARDEQT239015A, EQTXS3216 SAT12 - ARDSAT239016A, EQTXS3216 SAT13 - ARDSAT239017A, HOR 14 XD2 - ARDEQT239006A, HOR 14 XD2 - ARDEQT239006C, HOR 14 XO - ARDEQT269002A, HOR 14 XO - ARDEQT269002C, HOR 14 XS0 - ARDEQT239004A, HOR 14 XS0 - ARDEQT239004C, HOR 14 XS1 - ARDEQT239005A, HOR 14 XS1 - ARDEQT239005C, HOR 16 XD2 - ARDEQT239003A, HOR 16 XD2 - ARDEQT239003C, HOR 16 XO - ARD267900080A, HOR 16 XO - ARDEQT269003A, HOR 16 XO - ARDEQT269003C, HOR 16 XS0 - ARDEQT239001A, HOR 16 XS0 - ARDEQT239001C, HOR 16 XS1 - ARDEQT239002A, HOR 16 XS1 - ARDEQT239002C, SAT BRAINLAB 12 - ARD515070110A, SAT BRAINLAB 12 - ARD515070110C, SAT BRAINLAB 13 - ARD515071110A, SAT BRAINLAB 13 - ARD515071110C, SAT BRAINLAB CAMERA - ARDSAT269000C, SAT BRAINLAB CAMERA - ARDSAT269001C, SAT BRAINLAB CAMERA - ARDSAT269003A, SAT BRAINLAB CAMERA - ARDSAT269003C, SAT BRAINLAB CAMERA - ARDSAT269004A, SAT BRAINLAB CAMERA - ARDSAT269004C, SAT CAM 12 - ARD515031880A, SAT CAM 12 - ARD515031880C, SAT CAM 13 - ARD515032880A, SAT CAM 13 - ARD515032880C, SAT MEDIA - ARD2SAT00210A, SAT MEDIA - ARD2SAT00220A, SAT MHD214 - ARDSAT239011A, SAT MHD214 - ARDSAT239012A, SAT ORCHID - ARDSAT229000A, SAT ORCHID - ARDSAT229000C, SAT ORCHID - ARDSAT229001A, SAT ORCHID - ARDSAT229001C, SAT ORCHID - ARDSAT229003A, SAT ORCHID - ARDSAT229003C, SAT ORCHID - ARDSAT229004A, SAT ORCHID - ARDSAT229004C, SAT ORCHIDE 12 - ARD515031991A, SAT ORCHIDE 12 - ARD515031991C, SAT ORCHIDE 12 - ARDSAT229005A, SAT ORCHIDE 12 - ARDSAT229005C, SAT ORCHIDE 13 - ARD515032991A, SAT ORCHIDE 13 - ARD515032991C, SAT ORCHIDE 13 - ARDSAT229006A, SAT ORCHIDE 13 - ARDSAT229006C, SAT PERF 258S - ARD515053130A, SAT PERF 258S - ARD515053130C, SAT SC 071 - ARD515031140C, SAT SC 071 - ARD515032140C, SAT SC07 HOR - ARD2SAT00120C, SAT SHD 12 - ARD515031990C, SAT SHD 13 - ARD515032990C, SAT SHD HOR - ARD2SAT00150A, SAT SHD HOR - ARD2SAT00150C, SAT SSD 13 - ARD515032080A, SAT SUP CAM 12 - ARD515031730A, SAT SUP CAM 13 - ARD515032730A, SAT XD 241 - ARD515031660A, SAT XD 241 - ARD515031660C, SAT XD 241 - ARD515032660A, SAT X

    FDA Enforcement
    Class II ·Ongoing·Getinge Usa Sales Inc·January 24, 2024

    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

    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