10 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TPN TRAY (STERILE)
FDA 510(k)
FDA Class 2
·General Hospital
DePuy Songer Spinal Cable System
FDA UDI
Pioneer Surgical Technology, Inc.·10846468005273·Cable, ISOLA,Ti,W/Crmp 6-Pack,NS,AcroMed
Instrument Case
FDA UDI
KATENA PRODUCTS, INC.·00841668113189·STERILIZING CASE SMALL KATENA IOP
Songer® Spinal Cable System
FDA UDI
Pioneer Surgical Technology, Inc.·00840298704538·(6) Ø1.25mm Cable, ISOLA with Crimp, (10) Crimp...
ACETATE CONCENTRATES FOR HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP
FDA 510(k)
FDA Class 2
·Orthopedic
ZIMMER TRABECULAR METAL GLENOSPHERE
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSD·January 17, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 5, 2014
MAXIMO II CRT-D
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NIK·December 14, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024