13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517578204·CoRoent Ant TLIF PEEK, 9x13x32mm 0°
AGXO
FDA UDI
Oticon A/S·05707131341846·G100, BTE 13 PP 2.4G 105 C092 AGXO
CHIMAERA HIP FRACTURE SYSTEM
FDA UDI
ORTHOFIX SRL·18054242515494·DISTAL SCREWDRIVER
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198208·AK3 PS Insert Trial Size 3, 20mm
SYNTHES XRL
FDA 510(k)
FDA Class 2
·Orthopedic
DRYODINE CADEXOMER-IODINE GEL
FDA 510(k)
FDA Unclassified
·Unknown
SHUNT TUNNELER
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCICENCS IMPLANTS SA·Product code JXG·September 19, 2016
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 26, 2011
HS III PROXIMAL SEAL SYTEM 3.8MM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR,LLC·Product code DXC·June 25, 2013
PENUMBRA ASPIRATION TUBE
FDA Adverse Event
Death
·PENUMBRA·Product code DXE·September 29, 2016
OPHTALMIC PACK- (1) TABLE COVER REINF. 44" X 78" UF (1) GOWN SMS XLGE STD UF (2) TOWEL ABSORBENT 15" X 20" LIF (1) SYRINGE 3cc W/0 NDL LILOCK UF (1) MAYO STAND COVER REINF. LIF (1) NEEDLE HYPODERMIC 18G X 1% ST. UF (10) EYE MICRO SPONGE UF (2) LABEL CONTRAST BLUE (1) GOWN LGE STD SMS (1) WIPE INSTRUMENT 1MM (1) EYE DRAPE UF (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) IODINE POVIDONE 1oz. (1) EYE SHIELD UNIVERSAL L/F (10) APPLICATOR COTION 6" WOOD (1) BALANCED SALT SOLUTION 18ML LIF (10) GAUZE SPONGE 4" X 4" 12P Y UF (1) LABEL BSS (1) TRAY 3/COMPARTMENT LIF (1) LABEL EPINEPHRINE VIOLET/WHITE (1) LABEL IODINE WHITE/BLACK Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014