1,405 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SERIES 8000 BUCKY
FDA Adverse Event
Other
·LIEBEL-FLARSHEIM·Product code IXJ·March 18, 1994
1055MM CAMERA
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code IXJ·May 2, 2000
KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak DirectView CR 500 systems. Responsible firm on label: Made in U.S.A. by Eastman Kodak Company, Rochester, N.Y. 14650. Screens are sold in the following sizes and Cat. Nos: (1) Cat. #812-7334 - 15 x 30 cm; (2) Cat #825-9269 - 18 x 24 cm; (3) Cat #167-8663 - 24 x 30 cm; (4) Cat #810-7823 - 35 x 35 cm; (5) Cat #160-5906 - 35 x 43 cm
FDA Recall
Terminated
·Eastman Kodak Co·Product code IXJ·April 8, 2005
Grid, Radiographic
FDA classification
FDA Class 1
·Grid, Radiographic
Implant Removal Tool
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307119418·
Axi+Line Bunion Correction System
FDA UDI
Medartis Inc.·00817701028130·Axi+Line Plate 7.5 Degree Right
Axi+Line Bunion Correction System
FDA UDI
Medartis Inc.·00817701028123·Axi+Line Plate 7.5 Degree Left
Axi+Line Bunion Correction System
FDA UDI
Medartis Inc.·00817701028147·Axi-Line Plate 10.0 Degree Left
Axi+Line Bunion Correction System
FDA UDI
Medartis Inc.·00817701028116·Axi+Line Plate 5.0 Degree Right
Axi+Line Bunion Correction System
FDA UDI
Medartis Inc.·00817701028178·Axi+Line Plate 12.5 Degree Right
Axi+Line Bunion Correction System
FDA UDI
Medartis Inc.·00817701028154·Axi+Line Plate 10.0 Degree Right
Axi+Line Bunion Correction System
FDA UDI
Medartis Inc.·00817701028161·Axi+Line Plate 12.5 Degree Left
Axi+Line Bunion Correction System
FDA UDI
Medartis Inc.·00817701028109·Axi+Line Plate 5.0 Degree Left
Autoclavable version of PBag-inj
FDA UDI
PLASMABIOTICS·03701354404014·Autoclavable version of PBag-inj
MONOJECT PLASTIC DENTAL INJ. SYRINGE
FDA 510(k)
FDA Class 2
·Dental
FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100
FDA 510(k)
FDA Class 2
·Cardiovascular
FACTOR DEFICIENT PLASMAS - FACTOR IX (9)
FDA 510(k)
FDA Class 2
·Hematology
Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118 Database Server Upgrade A.0
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·March 7, 2018
1M ixing TIps short15 Lab Refill
FDA UDI
IVOCLAR VIVADENT, INC.·D7076668281·1M ixing TIps short15 Lab Refill
Matrix Pro II J-latch collet
FDA UDI
PRO-DEX, INC.·00856482008078·