3,839 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Quantum S2
FDA UDI
Pathcom Systems Corporation·G225QSSX370·The Slide Stainer is a fully automated slide pr...
ON-Q SS
FDA Adverse Event
Malfunction
·I-FLOW CORP.·Product code MEB·March 10, 2011
ON-Q SS CATHETER
FDA Adverse Event
Malfunction
·I-FLOW, LLC·Product code BSO·April 8, 2013
IN-HOME HIV TEST ORAQUICK
FDA Adverse Event
Malfunction
·ORASURE TECHNOLOGIES, INC.·Product code QSS·August 27, 2024
ORAQUICK
FDA Adverse Event
Malfunction
·ORASURE TECHNOLOGIES, INC.·Product code QSS·March 26, 2026
TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·May 30, 2021
CENTURION VISION SYSTEM, ACCESSORY, ACTIVE SENTRY HANDPIECE
FDA Adverse Event
Injury
·ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER·Product code HQC·January 22, 2024
CENTURION SURGICAL PROCEDURE PAK
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - HOUSTON·Product code LRO·March 5, 2026
CENTURION SURGICAL PROCEDURE PAK
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - HOUSTON·Product code LRO·March 4, 2026
CENTURION SURGICAL PROCEDURE PAK
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - HOUSTON·Product code LRO·March 4, 2026
CENTURION SURGICAL PROCEDURE PAK
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - HOUSTON·Product code LRO·March 4, 2026
CENTURION SURGICAL PROCEDURE PAK
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - HOUSTON·Product code LRO·March 12, 2026
CENTURION SURGICAL PROCEDURE PAK
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - HOUSTON·Product code LRO·March 5, 2026
CENTURION SURGICAL PROCEDURE PAK
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - HOUSTON·Product code LRO·March 4, 2026
CLEARCUT KNIVES
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - ALCON PRECISION DEVICE·Product code HNN·February 13, 2026
CLEARCUT KNIVES
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - ALCON PRECISION DEVICE·Product code HNN·February 13, 2026
CLEARCUT KNIVES
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - ALCON PRECISION DEVICE·Product code HNN·February 19, 2026
Hiv Self-Tests
FDA classification
FDA Class 3
·Hiv Self-Tests
Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FITMENT ON PUMP SEGMENT IS OPEN, Fluid path is STERILE and NONPYROGENIC. 12276678 Rev 00 -VersaSafe Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 2120-0500, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN. FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion, 630-01104 Rev 00 -SmartSite Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump REF 2420-0500,WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN. FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion, 630-00952 Rev 01 -Infusion Set Alaris Pump Module/Medley Pump Module REF 24009-0007T, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN, FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion 630-00650 Rev 00 Production Usage: Administration sets allow for the intravenous administration of fluids, medications, nutritional support and transfusion therapy through a needle or catheter inserted into the patient s artery or vein. The sets are comprised with components commonly found on intravascular administration sets and extension sets. The components include an Alaris Pump module silicone segment and fitments, drip chamber, check valve, one or more SmartSite needleless connectors, slide clamp, male luer with spin lock and tubing with different length of tubing.
FDA Enforcement
Class II
·Terminated·CareFusion 303, Inc.·November 14, 2018
DI ESSE S.R.L.
FDA registration
DI ESSE S.R.L.·2 products·🇮🇹 Italy