61 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
FDA Enforcement
Class II
·Ongoing·Greiner Bio-One North America, Inc.·November 5, 2025
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·April 12, 2017
BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·February 22, 2017
Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants Article Number: 115244
FDA Enforcement
Class II
·Terminated·Straumann Manufacturing, Inc.·November 21, 2018
Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Number: 044.210 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function
FDA Enforcement
Class II
·Terminated·Straumann Manufacturing, Inc.·January 18, 2017
Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function
FDA Enforcement
Class II
·Terminated·Straumann Manufacturing, Inc.·January 18, 2017
Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512
FDA Enforcement
Class II
·Terminated·Straumann Manufacturing, Inc.·August 24, 2016
Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
FDA Enforcement
Class II
·Terminated·Straumann Manufacturing, Inc.·August 24, 2016
Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115
FDA Enforcement
Class II
·Terminated·Straumann Manufacturing, Inc.·May 16, 2018
Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099
FDA Enforcement
Class II
·Terminated·Straumann Manufacturing, Inc.·May 16, 2018
Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W
FDA Enforcement
Class II
·Terminated·Straumann Manufacturing, Inc.·May 16, 2018
Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W
FDA Enforcement
Class II
·Terminated·Straumann Manufacturing, Inc.·May 16, 2018
Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
FDA Enforcement
Class II
·Terminated·Acumedia Manufacturers, Inc.·February 1, 2017
Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmental samples.
FDA Enforcement
Class II
·Terminated·Acumedia Manufacturers, Inc.·June 21, 2017
Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W
FDA Enforcement
Class II
·Terminated·Straumann Manufacturing, Inc.·May 16, 2018
Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113
FDA Enforcement
Class II
·Terminated·Straumann Manufacturing, Inc.·May 16, 2018
Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
FDA Enforcement
Class II
·Terminated·RGI Medical Manufacturing, Inc.·July 16, 2014
Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarch Airway Clearance System, Model 1000, is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physicians choice of treatment. It is indicated for patients having difficulty with secretion clearance or the presence of atelectasis caused by mucus plugging.
FDA Enforcement
Class II
·Terminated·HILL-ROM MANUFACTURING, INC.·December 6, 2017
Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air transport.
FDA Enforcement
Class II
·Terminated·Hill-Rom Manufacturing, Inc.·December 2, 2020
6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
FDA Enforcement
Class II
·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021