17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MILESTONE SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019
ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERIFY 270FP CHALLENGE PACK
FDA 510(k)
FDA Class 2
·General Hospital
BIPAP A30-S SILVER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·September 25, 2024
BIPAP A30, SILVER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·September 25, 2024
CORNERSTONE-SR TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 11, 2018
BIPAP A30
FDA Adverse Event
Death
·RESPIRONICS, INC.·Product code MNS·September 13, 2023
SPRINT QUATTRO SECURE S
FDA Adverse Event
Death
·MPRI·Product code LWS·May 29, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 18, 2011
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·August 21, 2008
JETSTREAM SC
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MCW·January 31, 2023
CORNERSTONE-SR TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·September 7, 2017
CORNERSTONE-SR® TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 6, 2025
CORNERSTONE-SR® TI-COATED CAGE SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code ODP·October 8, 2024
BIPAP A30-S SILVER
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·September 25, 2024
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024