13 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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ECHONAVIGATOR RELEASE 1
FDA 510(k)
FDA Class 2
·Radiology
Z Liquid HT OM2-S 100ml
FDA UDI
ARGEN CORPORATION, THE·D818121781·Dental porcelain/ceramic restoration kit
MacBite
FDA UDI
Surgimac LLC·D10512178EA1·Mac Bite Registration Material - 50ml
SurgiMac
FDA UDI
Surgimac LLC·D12178EA1·Mac Bite Registration Material - 50ml
EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GYMFORM DUAL FLEX BELT MODEL WB-162
FDA 510(k)
FDA Class 2
·Physical Medicine
CLEARVIEW UTERINE MANIPULATOR
FDA Adverse Event
Injury
·CLINICAL INNOVATIONS, LLC·Product code LKF·June 11, 2024
PERSONA TRABECULAR METAL 2 PEG TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code MBH·August 29, 2016
SCEPTER XC
FDA Adverse Event
Malfunction
·MICROVENTION, INC.·Product code DQY·December 6, 2023
V12 COVERED STENT
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORPORATION·Product code JCT·May 15, 2013
ADVIA CENTAUR
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JJE·September 26, 2014
CONSULTA CRT-D
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NIK·June 13, 2011
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024