22 results
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30ms
·
Sources: EU EUDAMED, US FDA
5MP MONOCHROME LCD MONITOR, RADIFORCE GX540
FDA 510(k)
FDA Class 2
·Radiology
ArgenZ HT+ 98x16 ML B1B
FDA UDI
ARGEN CORPORATION, THE·D818130336·Dental porcelain/ceramic restoration kit
N/A
FDA UDI
Tyber Medical, LLC·M695M1303360·
MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711
FDA 510(k)
FDA Class 2
·Microbiology
KMEDIC EXTERNAL FIXATION DEVICES
FDA 510(k)
FDA Class 2
·Orthopedic
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 22, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 18, 2014
REVEAL XT
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DSI·June 16, 2011
DENALI JUGULAR SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 27, 2023
HNM LATERAL ANCHOR
FDA Adverse Event
Injury
·HNM STAINLESS, LLC DBA HNM MEDICAL·Product code HWC·April 16, 2018
Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·November 25, 2020
DENALI JUGULAR SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 21, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 10, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 6, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 20, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 11, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·November 7, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 20, 2023
DENALI FEMORAL SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 9, 2023
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec AG·December 9, 2015