28 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR
FDA 510(k)
FDA Class 2
·Cardiovascular
IN00087 CLERMONT FERRAND PH
FDA Adverse Event
Death
·SORIN GROUP ITALIA·Product code DWF·March 7, 2014
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·January 7, 2016
INSPIRE 6F HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 21, 2022
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·June 8, 2016
ARGEDENT 74 (5 dwt)
FDA UDI
ARGEN CORPORATION, THE·D818120185·Gold based noble metal
NA
FDA UDI
Stryker GmbH·04546540504203·DRILL, WL 41MM, STRYKER SHAFT
PMT® CORPORATION HALO
FDA UDI
PMT CORPORATION·10650551045820·BREAKAWAY TORQUE DRIVERS
Diversatek Healthcare
FDA UDI
DIVERSATEK HEALTHCARE, INC.·M7831201850·Basic Endoscopy Procedure Kit
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197539975·Cushing Laminectomy Ronguer 5x10mm 180mm
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
SLEEP APP
FDA 510(k)
FDA Class 2
·Dental
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 5, 2023
ONE TOUCH PROFILE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·January 6, 2003
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 31, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 26, 2023
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·September 27, 2021
SOLETRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·May 12, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 18, 2016
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·May 16, 2023