11 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517578600·CoRoent Ant TLIF Ti, 12x11x32mm 4°
TASMIN R 22°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844015124·The basic shape of the TASMIN R devices is a ho...
FAA Airline - 24 Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588013244·FAA Airline - 24 Poly White
ALARIS SMARTSITE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FPA·January 26, 2026
AVT NATURASOFT
FDA 510(k)
FDA Class 2
·Ophthalmic
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM)
FDA 510(k)
FDA Class 2
·Orthopedic
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 3, 2014
MAXI LD LARGE DIAMETER DILATATION CATHETER
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code KNQ·August 24, 2011
CARE ASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·July 1, 2013
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030; c) PAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , Product Code/List Number/Item Code 65P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM AIRE-CUF , Product Code/List Number/Item Code 65P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM AIRE-CUF , Product Code/List Number/Item Code 65P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM AIRE-CUF , Product Code/List Number/Item Code 65P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM AIRE-CUF , Product Code/List Number/Item Code 65P055;
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024