27 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Elite Nitinol Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169502390·SCREW 2150125 SCREW 25MM
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490542401·TREPHINE INNER TRAY
3150-125 Sensor
FDA UDI
Tekscan, Inc.·B97031501250·3150-125 Sensor
SAV
FDA UDI
Diversified Products, Inc.·00037741915010·
TiLock
FDA UDI
Genesys Orthopedics Systems LLC·M719G1501250·Pre-Bent Rod
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120502·Guidewire 1.2x150mm Dbl Trocar
RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VISION SCIENCES FLEXIBLE ENT SCOPE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWQ·November 10, 2017
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWQ·November 10, 2017
IHEARTEST
FDA Adverse Event
Malfunction
·IHEAR MEDICAL, INC.·Product code EWO·August 17, 2022
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD·Product code NBW·December 31, 2013
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD·Product code NBW·July 10, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·June 3, 2013
SELOX SR 45
FDA Adverse Event
Malfunction
·BIOTRONIK GMBH AND CO.·Product code DTB·August 29, 2008
UNKNOWN SHOULDER LOCKING SCREW
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code LPH·June 24, 2024
UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code HSD·June 24, 2024
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·June 6, 2013