11 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RadCalc Software
FDA 510(k)
FDA Class 2
·Radiology
Contrast Line
FDA UDI
ARGON MEDICAL DEVICES, INC.·00886333207572·Contrast Line 96"(244cm) Male/Female Polyuretha...
EarQ
FDA UDI
Oticon A/S·05707131342003·G10, BTE 13 PP 2.4G 105 C091 EARQ
MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
HYPERION X9
FDA 510(k)
FDA Class 2
·Radiology
4 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·October 7, 2008
SECURE 3 MED/SURG BEDOBS 01/13
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 27, 2013
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCO·Product code LKK·July 13, 2011
FREESTYLE LIBRE 14 DAY
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC·Product code PZE·September 5, 2023
FREE STYLE LIBRE 2
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC.·Product code QLG·June 10, 2022
bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
FDA Enforcement
Class II
·Terminated·Beaver-Visitec International Inc.·February 7, 2018