22 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LDR SPINE ROI-A INTERBODY FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Bone cutters
FDA UDI
DFS - DIAMON GmbH·04057176163318·Bone cutter C162 HP 1,6mm
Lacrimal Cannula
FDA UDI
Medetz Surgical Instruments LLC·G22311032740·Bailey Lacrimal Cannula, 27g with 19g reinforce...
SURGICAL FACE MASK; SURGICAL FACE MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEARTWAY POWER CHAIR, P23
FDA 510(k)
FDA Class 2
·Physical Medicine
Iconacy i-Hip
FDA UDI
Iconacy Orthopedic Implants LLC·M914011032706200·HXLP LINER, 36MM I.D. X 62MM O.D., EXTD WALL
Iconacy i-Hip
FDA UDI
Iconacy Orthopedic Implants LLC·M914011032706400·HXLP LINER, 36MM I.D. X 64MM O.D., EXTD WALL
Iconacy i-Hip
FDA UDI
Iconacy Orthopedic Implants LLC·M914011032705800·HXLP LINER, 36MM I.D. X 58MM O.D., EXTD WALL
Iconacy i-Hip
FDA UDI
Iconacy Orthopedic Implants LLC·M914011032705400·HXLP LINER, 36MM I.D. X 54MM O.D., EXTD WALL
Iconacy i-Hip
FDA UDI
Iconacy Orthopedic Implants LLC·M914011032706000·HXLP LINER, 36MM I.D. X 60MM O.D., EXTD WALL
Iconacy i-Hip
FDA UDI
Iconacy Orthopedic Implants LLC·M914011032705600·HXLP LINER, 36MM I.D. X 56MM O.D., EXTD WALL
DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 7, 2025
VERSAFITCUP DOUBLE MOBILITY LINER Ø 54/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·November 15, 2017
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013
PRIME CARE (R) TRANSCEND ADVANCED MATTRESS
FDA Adverse Event
Malfunction
·PRIMUS MEDICAL, LLC·Product code IKY·September 10, 2014
ADVANTAGE SERIES 26
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·May 20, 2011
SENSATION PLUS 8FR. 50CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·May 10, 2022
SENSATION PLUS 7.5FR. 40CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 23, 2021
SENSATION 7FR. 34CC IAB
FDA Adverse Event
Death
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 2, 2021
Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·August 30, 2017