10,000 results · 34ms · Sources: EU EUDAMED, 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