14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIO-MODULAR SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471155992·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 230mm
QUIK-DOT C REACTIVE PROTEIN
FDA 510(k)
FDA Class 2
·Immunology
3M Clarity Aligners
FDA 510(k)
FDA Class 2
·Dental
PREMIER ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWQ·August 12, 2011
PREMIER® ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017
PREMIER® ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 3, 2017
PREMIER® ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 7, 2015
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·March 7, 2013
CONSULTA
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·February 15, 2011
ENPULSE DR
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code NVZ·August 8, 2014
GORE® DUALMESH® BIOMATERIAL
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code FTL·November 12, 2020
GORE® DUALMESH® BIOMATERIAL
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code FTL·November 12, 2020
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