16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PESSARY
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DR COMFORT
FDA UDI
DJO, LLC·00888912235600·Sheer ThighHs OT W 20-30 BLK M
HHM
FDA UDI
Oticon A/S·05707131258359·H160, MINIRITE 312 WL CBE HHM
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523184170·L CR E-CIMA Vitamin E Ultracongruent Tibial Ins...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523184415·L Ultracongruent Tibial Insert Trial Sz B 13mm
TOSHIBA 3T EXTRA LARGE KNEE COIL
FDA 510(k)
FDA Class 2
·Radiology
PATRIOT TRANSCONTINENTAL M SPACERS
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·January 6, 2020
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 1, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 29, 2013
RCIP/STERNUM SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 11, 2011
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·September 2, 2020
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·May 8, 2020
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·May 8, 2020
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021