20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRECICE UNYTE System
FDA 510(k)
FDA Class 2
·Orthopedic
External Fixation
FDA UDI
Life Spine, Inc.·00190837033941·3.8mm Short Drill
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613055486·Vitrectomy Blade, 20ga, Angled, Full Handle, Be...
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361036432·Trial Spacer, Center Stop, Assembly, Lordotic, 7mm
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361036487·Trial Spacer, Center Stop, Assembly, Lordotic, ...
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361036449·Trial Spacer, Center Stop, Assembly, Lordotic, 8mm
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361036470·Trial Spacer, Center Stop, Assembly, Lordotic, ...
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361036463·Trial Spacer, Center Stop, Assembly, Lordotic, ...
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361036418·Trial Spacer, Center Stop, Assembly, Lordotic, 5mm
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361036425·Trial Spacer, Center Stop, Assembly, Lordotic, 6mm
Arena-C®
FDA UDI
SPINEFRONTIER, INC.·00190361036456·Trial Spacer, Center Stop, Assembly, Lordotic, 9mm
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613103101·Precision Vitrectomy Blade 20 Gauge Angled On A...
MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY
FDA 510(k)
FDA Class 2
·Anesthesiology
TREVAIR CHAIR ADULT
FDA 510(k)
FDA Class 1
·Physical Medicine
DON'T KNOW MESH TYPE
FDA Adverse Event
Injury
·UNK·Product code FTM·July 15, 2011
PLUM A+ DRIVER REFUR
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 10, 2013
LIFEPAK CR PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·September 18, 2008
PEDICLE SCREW LATERAL CONNECTOR L150
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2023
MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NKM·July 7, 2017
REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·May 13, 2020