15 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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Tyvek Sterilization Pouches with Chevron Seal
FDA 510(k)
FDA Class 2
·General Hospital
INBONE
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420196309·Poly Removal Tool, Retangular Housing
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780466741·Integra® Jarit® Sofield Retractor, Double-Ended...
ELMED
FDA UDI
ELMED INCORPORATED·00842180149885·CLEANING BRUSH FOR VERESS NEEDLE, EACH
Evans Trial
FDA UDI
Treace Medical Concepts, Inc.·00810111224253·TMC Evans Trial, 12mm
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885425962297·PICC CENTRAL LINE W BIOPATCH
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 28, 2022
ENDOSCOPIC CAMERA MC404/C3
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E
FDA 510(k)
FDA Class 2
·Immunology
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·September 10, 2020
T:SLIM X2 INSULIN PUMP
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·October 24, 2017
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDI·October 24, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 1, 2013
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014