1,572 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Wright EVOLVE TRIAD Plate Cutter, REF 49510120
FDA Recall
Open, Classified
·Wright Medical Technology, Inc.·Product code QLR·June 14, 2022
Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
FDA classification
FDA Class 2
·Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Component 5LR (5/pk), TS Crown Component 6LR (5/pk), TS Crown Component 4UL (5/pk), TS Crown Component 5UL (5/pk), TS Crown Component 4LL (5/pk), TS Crown Component 5LL (5/pk), and TS Crown Component 6LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance
FDA Enforcement
Class II
·Terminated·Specialty Appliance Works, Inc.·April 29, 2015
TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown Component 7LR (5/pk), TS ROC Crown Component 8LR (5/pk), TS ROC Crown Component 4UL (5/pk), TS ROC Crown Component 5UL (5/pk), TS ROC Crown Component 6UL (5/pk), TS ROC Crown Component 7UL (5/pk), TS ROC Crown Component 8UL (5/pk), TS ROC Crown Component 4LL (5/pk), TS ROC Crown Component 5LL (5/pk), TS ROC Crown Component 6LL (5/pk), TS ROC Crown Component 7LL (5/pk), TS ROC Crown Component 8LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
FDA Enforcement
Class II
·Terminated·Specialty Appliance Works, Inc.·April 29, 2015
QFR SOLUTIONS BV
FDA registration
QFR SOLUTIONS BV·2 products·🇳🇱 Netherlands
CLR MEDICAL, INC.
FDA registration
CLR MEDICAL, INC.·2 products·🇺🇸 United States
SENSATION CATHETER
FDA Adverse Event
Injury
·GETINGE·Product code DSP·May 7, 2024
TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Component 5LR (5/pk), TS Crown Component 6LR (5/pk), TS Crown Component 4UL (5/pk), TS Crown Component 5UL (5/pk), TS Crown Component 4LL (5/pk), TS Crown Component 5LL (5/pk), and TS Crown Component 6LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance
FDA Recall
Terminated
·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015
TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown Component 7LR (5/pk), TS ROC Crown Component 8LR (5/pk), TS ROC Crown Component 4UL (5/pk), TS ROC Crown Component 5UL (5/pk), TS ROC Crown Component 6UL (5/pk), TS ROC Crown Component 7UL (5/pk), TS ROC Crown Component 8UL (5/pk), TS ROC Crown Component 4LL (5/pk), TS ROC Crown Component 5LL (5/pk), TS ROC Crown Component 6LL (5/pk), TS ROC Crown Component 7LL (5/pk), TS ROC Crown Component 8LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.
FDA Recall
Terminated
·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015
POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
I-Series Washers
FDA UDI
SKYTRON LLC·10841736100360·I5 Universal two level processing rack, with 1 ...
I-Series Washers
FDA UDI
SKYTRON LLC·10841736100377·I5 Three level processing rack, with 2 rotating...
ROC Crown 3LR
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199001470·
SS Crown 2LR
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199001070·
SS Crown 3LR
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199001080·
I-Series Washers
FDA UDI
SKYTRON LLC·10841736100384·I5 Four level processing rack, with 3 rotating ...
MEDICAL DISPLAY, MDC1900-1LG (1LR)
FDA 510(k)
FDA Class 2
·Radiology
KENEX
FDA UDI
KENEX (ELECTRO-MEDICAL) LIMITED·05055449415743·1340/3/LR Mob Tableside Control Pedestal (7.7x2...
CLR Port
FDA UDI
CLR Medical·00860003054918·