15 results · 23ms · Sources: EU EUDAMED, 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