15 results
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8ms
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Sources: EU EUDAMED, US FDA
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Classification: Class I
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CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.
FDA Enforcement
Class I
·Terminated·TERRIFIC CARE LLC·February 13, 2019
Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Portex Unit Dose 15 ml Normal Saline ¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Medline Prefilled 550 ml Sterile¿¿ ¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
FDA Enforcement
Class I
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·February 13, 2019
Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
FDA Enforcement
Class I
·Terminated·Atossa Genetics, Inc.·November 6, 2013