15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LeForte System II
FDA 510(k)
FDA Class 2
·Dental
AGXO
FDA UDI
Oticon A/S·05707131283245·H110V2, MINIBTE 312 WL 85 CNB AGXO
SSW CARBIDE TRIMMING AND FINISHING
FDA UDI
Ss White Burs, Inc.·D6901509652·12 BLADE FINISHING CARBIDE 7583 - 5 PACK
TRANS1 AXIALIF SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 6, 2013
AUGMENTED INSERT
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code KWA·June 29, 2011
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code MLV·September 9, 2008
DIVA
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 7, 2020
DIVA
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·July 7, 2020
SENRI
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code DQY·December 25, 2016
ROI-C IMPLANT, UNKNOWN SIZE
FDA Adverse Event
Injury
·LDR MÉDICAL·Product code OVE·September 21, 2021
BD SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 8, 2019
METACROSS RX PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LIT·October 15, 2019
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022