11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POWER WHEELCHAIR - TILT & RECLINE SEATING SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154677061·CRYER EXTRACTION FORCEPS #151S
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613119744·Universal Trial Frame, Adult Size, Accommodates...
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756397001·MAJOR BASIN PACK
EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JKH Stimulator Plus
FDA 510(k)
FDA Class 2
·Neurology
TRELLIS 8 120X30
FDA Adverse Event
Injury
·COVIDIEN·Product code KRA·January 11, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·November 30, 2010
ARMADA 35 PTA CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LIT·July 2, 2014
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·September 25, 2023