19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRU Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
AGXO
FDA UDI
Oticon A/S·05707131283276·H110V2, MINIBTE 312 WL 85 DBL AGXO
PROFLU+ ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 6, 2013
HIP HEAD, 10/12 TAPER, 28MM,+0MM
FDA Adverse Event
Injury
·DEPUY INTL. LTD.·Product code KWY·June 29, 2011
ETS- ENDOSCOPIC LINEAR CUTTER (VASCULAR/THIN) - 35 MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 28, 2008
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·April 28, 2021
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·September 12, 2018
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·September 14, 2018
FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·September 14, 2018
FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·April 23, 2021
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·June 14, 2021
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·April 26, 2021
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·June 13, 2019
FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·September 12, 2018
FLIPPER MREYE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·September 12, 2019
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·October 11, 2022
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