10,000 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POLY-LEC SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
Otocheck LE Case service kit
FDA UDI
OTODYNAMICS LIMITED·05060396172830·Case (enclosure) service kit for Otocheck LE
TSA W/LEC. & TWEEN. 80
FDA 510(k)
FDA Class 1
·Microbiology
ClearLook LEC, Sample Pack-Curettes Only
FDA UDI
Bionix, LLC·00714646001573·ClearLook LEC, Sample Pack-Curettes Only - with...
TSA W/LEC, PS80
FDA Adverse Event
Malfunction
·THERMO FISHER SCIENTIFIC·Product code LIB·May 22, 2017
Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8, The GoTo Seat is a light-weight, portable, postural support seat for kids, aged between 1 and 8 with disabilities.
FDA Enforcement
Class II
·Ongoing·James Leckey Design Ltd·April 15, 2020
CADD® CADD-PRIZM® VIP SYSTEM
FDA Adverse Event
Malfunction
·SMITHS MEDICAL, ASD, INC.·Product code FRN·July 30, 2018
Single Use Electrosurgical Knife KD-612
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code KNS·December 15, 2021
CADD LEGACY PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·March 25, 2020
CADD SOLIS VIP PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD,INC·Product code FRN·December 25, 2019
CADD LEGACY 1 PUMPS - 6400
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·August 1, 2023
CADD LEGACY PCA AMBULATORY INFUSION SYSTEM
FDA Adverse Event
Malfunction
·ST PAUL·Product code MEA·August 9, 2023
LIFELINE EMERGENCY CART
FDA Adverse Event
Malfunction
·INTERMETRO INDUSTRIES CORPORATION·Product code BZN·September 1, 2009
CADD-LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·December 12, 2019
CADD LEGACY PCA PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code MEA·February 16, 2024
CADD LEGACY PLUS AMBULATORY INFUSION SYSTEM
FDA Adverse Event
Malfunction
·NULL·Product code FRN·July 20, 2023
CADD LEGACY PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·September 24, 2019
CADD LEGACY PCA AMBULATORY INFUSION SYSTEM
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code MEA·June 7, 2024
CADD-SOLIS AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC·Product code MEA·June 18, 2024
CADD-LEGACY PUMPS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·November 20, 2018