7 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOLLOID ALL PURP 10CT, Model Number: MJ18005V2; 3) MJ BNDG HYDROCOLLOID FINGER TOE 8CT, Model Number: MJ76126V2; 4) WALMART,BANDAGE,HYDROCOLLOID,HEEL,6CT, Model Number: WAL1901; 5) WALMART,HYDROCOLLOID,TOE,8CT, Model Number: WAL1902;
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 16, 2025
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right.
FDA Enforcement
Class II
·Ongoing·TMJ Solutions Inc·October 2, 2024
Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
FDA Enforcement
Class II
·Ongoing·EMD Millipore Corporation·March 6, 2024
Lugol s Iodine Solution 500ML, Part Number 624-71
FDA Enforcement
Class II
·Ongoing·EMD Millipore Corporation·December 6, 2023
Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibular joint. It is indicated for patients with one or more of the following conditions: Inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment; Recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment; Failed tissue graft; Failed alloplastic joint reconstruction; Loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion
FDA Enforcement
Class II
·Terminated·TMJ Solutions Inc·April 25, 2018
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
FDA Enforcement
Class I
·Ongoing·TMJ Solutions Inc·November 26, 2025
Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister). The suction unit is intended for professional use to remove fluids from a patient's airway or respiratory support unit. The intended population for this device is s both adult and pediatric.
FDA Enforcement
Class II
·Terminated·EMG Technology Co., Ltd.·September 24, 2014