10 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
FDA Enforcement
Class II
·Ongoing·IsoTis OrthoBiologics, Inc.·January 22, 2025
ViewPoint; system, imaging processing, radiological
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·September 25, 2024
AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed.
FDA Enforcement
Class III
·Ongoing·Linet Americas·August 19, 2020
VACUETTE SAFELINK, REF: 450210
FDA Enforcement
Class II
·Ongoing·Greiner Bio-One GmbH·January 15, 2025
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
FDA Enforcement
Class II
·Ongoing·Greiner Bio-One North America, Inc.·January 24, 2024
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
FDA Enforcement
Class II
·Ongoing·Greiner Bio-One North America, Inc.·July 24, 2024
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
Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)
FDA Enforcement
Class II
·Ongoing·Greiner Bio-One North America, Inc.·November 26, 2025
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·September 25, 2024
REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
FDA Enforcement
Class II
·Ongoing·Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.·January 31, 2024