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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·