5 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery. ii. TxTiHA The Innovasis TxTiHA IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.
FDA Enforcement
Class II
·Ongoing·Innovasis, Inc·September 25, 2024
iLet Bionic Pancreas, REF: BB1001
FDA Enforcement
Class II
·Ongoing·Beta Bionics, Inc.·May 6, 2026
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
FDA Enforcement
Class II
·Ongoing·Beta Bionics, Inc.·April 22, 2026
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
FDA Enforcement
Class II
·Ongoing·Btt Health Gmbh·September 25, 2024
iLet Bionic Pancreas, REF: BB1001
FDA Enforcement
Class II
·Ongoing·Beta Bionics, Inc.·June 24, 2026