17 results
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19ms
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Sources: EU EUDAMED, US FDA
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
FDA Enforcement
Class II
·Terminated·Cardio Medical Products·July 17, 2013
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.
FDA Enforcement
Class II
·Terminated·POM Medical LLC·November 6, 2019
CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
FDA Enforcement
Class III
·Terminated·Cardiovascular Systems, Inc.·March 5, 2014
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
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
FDA Enforcement
Class II
·Terminated·Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company·November 28, 2018