9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813035245·K-Type Files 31MM #60
FORET Ø4,5 A BUTEE A EMBOUT AO
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489508561·
LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
Reform Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·September 16, 2011
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 14, 2014
WHEELCHAIR ACCESSORY
FDA Adverse Event
FINE GROUP·Product code INE·July 29, 2013
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016