10 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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Optima XR646 HD
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100851·MCNEILL GLOBAL FIXATION RING MEDIUM
HUMELOCK REVERSED
FDA UDI
FX SOLUTIONS·03701037303740·HUMELOCK REVERSED STEM TA6V Ø36/12 CEMENTLESS L...
URIC ACID (AOX), SCAL, NORTROL, ABTROL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISA ENZ 2 CAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
11 CM ANGLE ATTACHMENT QD11
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 15, 2014
ENDOVIVE? SECURI-T?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·June 17, 2013
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 23, 2011
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025