4 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Osteomed, LLC·June 10, 2020
OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 813845020061 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Skeletal Kinetics, Llc·July 22, 2020
Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP; Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-12BUP; Immutest 5 panel, Item No. IMCA-5AB-W; Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W; Immutest 7 panel, Item No. IMCA-7P; ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿
FDA Enforcement
Class II
·Terminated·Ameditech Inc·November 25, 2015
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 28, 2026