14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)
FDA 510(k)
FDA Unclassified
·Unknown
COMPREHENSIVE SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304677364·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197453301·CCR Titanium Longitudinal Blade
24x70m...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197084154·TC Foster Gillies Needle Holder
angled...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197084253·TC Berry Wire Holding Forceps
straig...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197084178·TC Webster Needle Holder
straig...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197084208·GILLIES TC Needle Holder
160mm,...
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL
FDA 510(k)
FDA Class 2
·Microbiology
CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 24, 2024
HANAULUX 3000
FDA Adverse Event
Malfunction
·MAQUET S.A.S·Product code FSY·October 15, 2014
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·June 20, 2013
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 27, 2011
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025