8 results
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7ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·February 17, 2021
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers. 1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16. 2. Anterior Column Plate; Article Numbers: 21218-14, 21219-14. 3. Biplanar 2-Column Plate; Article Numbers: 21216-10, 21216-12, 21217-10, 21217-12. 4. Cancellous Screw; Article Numbers: 30591-36, 30591-70, 30591-75, 30591-80, 30591-85, 30591-90. 5. Cancellous Screw, Locking; Article Numbers: 37422-12-N, 37422-14-N, 37422-16-N, 37422-18-N, 37422-20-N, 37422-22-N, 37422-24-N, 37422-26-N, 37422-28-N, 37422-30-N, 37422-32-N, 37422-34-N, 37422-36-N, 37422-38-N, 37422-40-N, 37422-42-N, 37422-44-N, 37422-46-N, 37422-48-N, 37422-50-N, 37422-55-N, 37422-60-N, 37422-65-N, 37422-70-N, 37422-75-N, 37422-80-N, 37422-85-N, 37422-90-N, 37422-95-N, 37422-100-N, 37422-105-N, 37422-110-N, 37422-115-N, 37422-120-N, 37592-18, 37592-20, 37592-22, 37592-24, 37592-26, 37592-28, 37592-30, 37592-32, 37592-34, 37592-36, 37592-38, 37592-40, 37592-42, 37592-46, 37592-48, 37592-50, 37592-54, 37592-56, 37592-58, 37592-60, 37592-65, 37592-70, 37592-75, 37592-80, 37592-85, 37592-90. 6. Cannulated Screw, Cancellous; Article Numbers: 31851-60, 31851-65, 31851-70, 31851-75, 31851-80, 31851-85, 31851-90, 31851-95, 31851-100, 31851-105, 31851-110, 31851-115, 31851-120, 31851-125, 31851-130, 31851-135, 31851-140, 31851-145, 31851-150, 31851-155, 31851-160, 31851-165, 31851-170, 31851-175, 31851-180, 31851-185, 31851-190, 31851-195, 31851-200, 31854-60, 31854-65, 31854-70, 31854-75, 31854-80, 31854-85, 31854-90, 31854-95, 31854-100, 31854-105, 31854-110, 31854-115, 31854-120, 31854-125, 31854-130, 31854-135, 31854-140, 31854-145, 31854-150, 31854-155, 31854-160, 31854-165, 31854-170, 31854-175, 31854-180, 31854-185, 31854-190, 31854-195, 31854-200. 7. Cortical Screw; Article Numbers: 32351-10, 32351-12, 32351-14, 32351-16, 32351-18, 32351-20, 32351-22, 32351-24, 32351-26, 32351-28, 32351-30, 32351-32, 32351-34, 32351-36, 32351-38, 32351-40, 32351-42, 32351-44, 32351-46, 32351-48, 32351-50, 32351-55, 32351-60, 32351-65, 32351-70, 32351-75, 32351-80, 32351-85, 32352-16, 32352-18, 32352-20, 32352-22, 32352-24, 32352-26, 32352-28, 32352-30, 32352-32, 32352-34, 32352-36, 32352-38, 32352-40, 32352-42, 32352-44, 32352-46, 32352-48, 32352-50, 32352-55, 32352-60, 32352-65, 32352-70, 32352-75, 32352-80, 32352-85, 32352-90, 32352-95, 32352-100, 32352-105, 32352-110, 32352-115, 32352-120, 32455-18, 32455-20, 32455-22, 32455-24, 32455-26, 32455-28, 32455-30, 32455-32, 32455-34, 32455-36, 32455-38, 32455-40, 32455-42, 32455-44, 32455-46, 32455-48, 32455-50, 32455-52, 32455-54, 32455-56, 32455-58, 32455-60, 32455-65, 32455-70, 32455-75, 32455-80, 32455-85, 32455-90, 32475-32. 8. Cortical Screw, Locking; Article Numbers: 37455-18, 37455-20, 37455-22, 37455-24, 37455-26, 37455-28, 37455-30, 37455-32, 37455-34, 37455-36, 37455-38, 37455-40, 37455-42, 37455-44, 37455-46, 37455-48, 37455-50, 37455-52, 37455-54, 37455-56, 37455-60, 37455-65, 37455-70, 37455-75, 37455-80, 37455-85, 37455-90. 9. Curved Plate; Article Numbers: 211911-4, 211911-5, 211911-6, 211911-7, 211911-8, 211911-10, 211911-12, 211911-14, 211911-16, 211911-20. 10. Posterior Column Plate, Left; Article Numbers: 212121-6. 11. Posterior Column Plate, Right; Article Numbers: 212131-6. 12. Posterior Wall Plate, Extended, Left; Article Numbers: 212101-SM. 13. Posterior Wall Plate, Extended, Left; Article Numbers: 212101-LA. 14. Posterior Wall Plate, Extended, Right; Article Numbers: 212111-LA, 212111-SM. 15. Posterior Wall Plate, Left; Article Numbers: 212141-7, 212141-8. 16. Posterior Wall Plate, Right; Article Numbers: 212151-7, 212151-8. 17. PRS Plate; Article Numbers: 21194-6, 21194-7, 21194-8, 21195-10, 21195-12, 21195-7. 18. Quadrilateral Buttress Plate; Article Numbers: 21208-13, 21209-13. 19. Quadrilateral Buttress Plate; Article Numbers: 21208-11, 21209-11. 20. Rim Plate, Left; Article
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014