8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PENETREASE
FDA 510(k)
FDA Class 2
·General Hospital
DeltaForm HD
FDA UDI
Merz Dental GmbH·D7091980078·DeltaForm HD upper posteriors, XS, B3 -MADE IN ...
Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
FDA 510(k)
FDA Class 2
·Orthopedic
OXYGENATOR, BUBBLE TYPE
FDA 510(k)
FDA Class 2
·Cardiovascular
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 22, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 24, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 2, 2014
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022