60 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO
FDA 510(k)
FDA Class 2
·Immunology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814220·GENUMEDI PT SILVER L V
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814282·GENUMEDI PT SILVER R V
ORTHOFIX
FDA UDI
ORTHOFIX SRL·18059015374315·STANDARD LOCKING SCREW L22.5MM D4.0MM
ORTHOFIX
FDA UDI
ORTHOFIX SRL·18059015373813·STANDARD LOCKING SCREW L22.5MM D4.0MM STERILE
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K1102250·Tray, Base, 2.25", Universal
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780433583·Integra® Jarit® Mixter Forceps, Full Horizontal...
PULSE OXIMETER MODEL P10
FDA 510(k)
FDA Class 2
·Cardiovascular
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Truliant
FDA UDI
Exactech, Inc.·10885862314994·Truliant CR Porous Femoral
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·September 17, 2019
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 8, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 12, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 27, 2022
BATTERY FOR BATTERY POWER LINE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code MOQ·May 31, 2013
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·June 25, 2011
COZMO INSULIN PUMP
FDA Adverse Event
Injury
·SMITHS MEDICAL MD (FORMERLY DELTEC, INC.)·Product code LZG·August 29, 2008
HF UNIT "ESG-400"
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GEI·April 23, 2021
HF UNIT "ESG-400"
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code GEI·December 5, 2017
HF UNIT "ESG-400"
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GEI·July 8, 2020