11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Recall
Terminated
·TMJ Solutions Inc·Product code LZD·March 12, 2018
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
Hypodermic Needle-Pro 5 ml Syringe, 21g x 1'' Needle Catatlog Number: 4253
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code FMJ·September 9, 2004
Portex Hypodermic Needle-Pro 5 ml Syringe, 22g x 1 '' Needle Catalog Number: 4254
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code FMJ·September 9, 2004
Portex Hypodermic Needle-Pro 5 ml Syringe, 21g x 1 '' Needle Catalog Number: 4252
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code FMJ·September 9, 2004
Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen
FDA Recall
Terminated
·Immuno-Mycologics, Inc·Product code GMJ·November 4, 2019
Lumbar Tray Catalog 1091
FDA Recall
Terminated
·Busse Hospital Disposables, Inc.·Product code FMJ·February 22, 2022
Portex Hypodermic Needle-Pro 5 ml Syringe, 20g x 1'' Needle Catalog Number: 4251
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code FMJ·September 9, 2004
Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues.
FDA Recall
Terminated
·DJO, LLC·Product code IMJ·August 21, 2015
Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis
FDA Recall
Terminated
·Immuno-Mycologics, Inc·Product code GMJ·May 9, 2016
Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS EUROPE) --- Manufacturer ECM B.V. Oost-Om 54, P.O. Box 53, NL 5420 AB GEMERT --- Shipping or Unit Package: 20 individual units packaged per box with 6 boxes per case. --- Device Classification Name: Electrode, pacemaker, temporary. ---The device is supplied sterile and intended for single use. Used to pace the heart during or after open heart surgery. The electrodes are placed on the heart; the other end of the pacing wire is inserted through the skin of the patient with a thoracic needle. The thoracic needle can snap-off at the end where the pacing wire is attached, after snap-off the remaining pins are connected to an external pacemaker. For temporary atrial and ventrical pacing and sensing for contemplated implant duration of 7 days or less.
FDA Recall
Terminated
·European Custom Manufacturing B.V. Oost-Om 54 Gemert Netherlands·Product code LDF·April 18, 2011