11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VoqX Electronic Stethoscope
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252096030·LeFort I Plate, 9mm advancement, right
Plateau-C Ti
FDA UDI
Life Spine, Inc.·00190837067267·Custom Small Anatomical Spacer, 7degree, 9mm
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (GREEN)
FDA 510(k)
FDA Class 1
·General Hospital
STIMULATION/DISSECTION INSTRUMENTS
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CERTAIN GOLD-TITE HEXED SCREW
FDA Adverse Event
Malfunction
·ZIMVIE US CORP LLC·Product code NHA·February 25, 2026
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 6, 2025
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·July 12, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·October 22, 2008
CORE MICRO DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·July 9, 2013
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023