19 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FACTOR XI DEFICIENT PLASMA
FDA 510(k)
FDA Class 2
·Hematology
Arthrex®
FDA UDI
ARTHREX, INC.·00888867050624·LO-PRO SCRW,TI,3.5MMX 36MM
ASTRA TOTAL PROTEIN REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
PROXIMATE ILS CIRCULAR STAPLES
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code GAG·June 7, 2006
PROXIMATE ILS CIRCULAR STAPLERS
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code GAG·June 7, 2006
CASING FOR 12V BATTERY
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·June 25, 2014
OCTRODE LEAD KIT, 60CM LENGTH
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·July 6, 2015
CLINICAL CHEMISTRY PHENOBARBITAL
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JJC·January 2, 2013
LOCKING SCREW, TITANIUM 3.5MM X 22MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·April 18, 2019
LO-PRO SCRW,TI,3.5MMX 26MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·April 18, 2019
LO-PRO SCRW,TI,3.5MMX 38MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·April 18, 2019
LO-PRO SCRW,TI,3.5MMX 30MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·April 18, 2019
CALCANEAL FRAC PERIMETER PLT,XS,RT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·April 18, 2019
LO-PRO SCRW,TI,3.5MMX 24MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·April 18, 2019
LO-PRO SCRW,TI,3.5MMX 34MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·April 18, 2019
LO-PRO SCRW,TI,3.5MMX 36MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·April 18, 2019
LOCKING SCREW, TITANIUM 3.5MM X 28MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·April 18, 2019
Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·June 8, 2016