280 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OsteoMed
FDA UDI
OSTEOMED LLC·00845694031615·Washer, 3.0mm Cannulated Screws
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K1102250·Tray, Base, 2.25", Universal
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0602250·Tray, Base, 2.25"
OsteoMed
FDA UDI
OSTEOMED LLC·00845694068185·Washer 3.0mm Canulated Screws Sterile Qty 5
PULSE OXIMETER MODEL P10
FDA 510(k)
FDA Class 2
·Cardiovascular
NUVASIVE SPHERX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·September 7, 2021
ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·December 20, 2017
ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·March 14, 2019
FCG KIT, NEEDLE, BIOPSY
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·April 6, 2020
FCG KIT, NEEDLE, BIOPSY
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·April 7, 2020
FCG KIT, NEEDLE, BIOPSY
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·April 6, 2020
ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·November 23, 2017
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 14, 2023
ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·December 9, 2020
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 10, 2013
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FRN·September 19, 2014
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 20, 2015
ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·April 30, 2018