BEUDAMED
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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 Enforcement
    Class II ·Terminated·TMJ Solutions Inc·April 25, 2018

    PML --IDS Rapid NH QC Set- Quality Control kit for culture media. Product label includes LyfoCults IVD , Lot # 134-1 Exp 02AUG2008. PML Micrcobiologicals 27120 SW 95th Avenue Wilsonville, Oregon 97070

    FDA Recall
    Terminated ·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007

    PML -- Vitek NH ID Card (NHI) Set - Quality Control kit for culture media. Each kit includes a 5 pack of LyfoCults Haemophilus parainfluenzae - Lot # 185-1 Exp 13AUG2008. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070

    FDA Recall
    Terminated ·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007

    PML -- LyfoCults Haemophilus parainfluenzae - micro organism. Product label includes LyfoCults Haemophilus parainfluenzae ATCC 7901 Lot No.: 233851-1 Exp 05-17-09. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070

    FDA Recall
    Terminated ·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007

    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

    Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates

    FDA Recall
    Terminated ·Pml Microbiologicals Inc.·Product code JSO·August 17, 2007

    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

    Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA Catalog #P1174

    FDA Recall
    Terminated ·Pml Microbiologicals Inc.·Product code JSO·April 23, 2007

    Advisor Vital Signs Monitor model 9200, catalog number 925454325. Item Description 9200 II 3LD/RP/02/IP/TP/BAT MDD. The basic monitoring package includes ECG (3 lead / 5 lead), impedance respiration, non-invasive blood pressure, pulse oximetry, two invasive blood pressures, and tow temperature channels. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·January 5, 2005

    Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654225.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005

    Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925574325.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005

    Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925754335.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005

    Advisor Vital Signs Monitor (model 9200), catalog number 925454225, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 50 Hz ECG, Standard SPO2 option and battery.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·September 1, 2005