10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BILE ACIDS REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VuePoint
FDA UDI
Nuvasive, Inc.·00887517176424·VuePoint II Template, 120mm Rod
Para-Pak Macro-CON
FDA UDI
MERIDIAN BIOSCIENCE, INC.·00840733102028·Para-Pak Macro-CON is a system for the concentr...
artegral
FDA UDI
Merz Dental GmbH·D7091970120·anteriors; shade A4; mould BL
AUTOVENT MODEL 4000
FDA 510(k)
FDA Class 2
·Anesthesiology
EndoRotor
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ARCHITECT IPTH
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code CEW·February 20, 2013
EVOLIS TIBIAL BASE PLATE TI PLASMA SPRAYED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 14, 2011
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code KWA·July 31, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021