11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Jumong General
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777587·LUMBAMED BASIC DORSAL STAY WM SILVER I
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777433·LUMBAMED PLUS FLEX PAD WM SILVER I
Adler Instrument Company
FDA UDI
Adler, Inc.·00810123207596·Jefferson Fcps 7" 1x2 Teeth
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573020546·INTRG WHISP-Z MBT ANT -6T 0A 018 LO
TempSure System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
REPIPHYSIS DISTAL FEMUR
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KRO·November 13, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 16, 2013
dS Breast 7ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024