BEUDAMED
    21 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 15, 2014

    Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 15, 2014

    TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460

    FDA Enforcement
    Class II ·Terminated·Quality Electrodynamics LLC·October 9, 2019

    TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453

    FDA Enforcement
    Class II ·Terminated·Quality Electrodynamics LLC·October 9, 2019

    TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464

    FDA Enforcement
    Class II ·Terminated·Quality Electrodynamics LLC·October 9, 2019

    TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525

    FDA Enforcement
    Class II ·Terminated·Quality Electrodynamics LLC·October 9, 2019

    TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524

    FDA Enforcement
    Class II ·Terminated·Quality Electrodynamics LLC·October 9, 2019

    TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829

    FDA Enforcement
    Class II ·Terminated·Quality Electrodynamics LLC·October 9, 2019

    TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828

    FDA Enforcement
    Class II ·Terminated·Quality Electrodynamics LLC·October 9, 2019

    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree

    FDA Enforcement
    Class II ·Ongoing·Wilson-Cook Medical Inc.·December 13, 2023

    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree

    FDA Enforcement
    Class II ·Ongoing·Wilson-Cook Medical Inc.·December 13, 2023

    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree

    FDA Enforcement
    Class II ·Ongoing·Wilson-Cook Medical Inc.·December 13, 2023

    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree

    FDA Enforcement
    Class II ·Ongoing·Wilson-Cook Medical Inc.·December 13, 2023

    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree

    FDA Enforcement
    Class II ·Ongoing·Wilson-Cook Medical Inc.·December 13, 2023

    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree

    FDA Enforcement
    Class II ·Ongoing·Wilson-Cook Medical Inc.·December 13, 2023

    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree

    FDA Enforcement
    Class II ·Ongoing·Wilson-Cook Medical Inc.·December 13, 2023

    Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD) e.g. rheumatoid arthritis if bone quality is adequate. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives. The system is intended for use either with or without bone cement in total hip arthroplasty."

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 2, 2016

    NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer variou sizes Product Usage "" The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating is indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). " The Natural-Knee II primary components without CSTi Porous Coating, all posterior stabilized and revision components, the N-K II Constrained Knee System, the modular cemented tibial baseplate, and the revision stem and revision fluted stem are indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact. " The Natural-Knee II Durasul polyethylene components are indicated for patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. These devices are intended for cemented use only in the United States."

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 2, 2016

    GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS¿ N-K FLX GSF NP FEM SZ 0 RT N-K FLX GSF NP FEM SZ 4 LT N-K FLX GSF NP FEM SZ 4 RT Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM POR Flex prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). " Components without CSTi porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. " The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex, NexGen CR-Flex Mobile*, NexGen UC-Flex Mobile*, NexGen Trabecular Metal" CR Monoblock, 90-prefix NexGen CR, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong¿ Highly Crosslinked Polyethylene CR articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees."

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 2, 2016