20 results · 23ms · Sources: EU EUDAMED, 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