835 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Solanas
FDA UDI
ALPHATEC SPINE, INC.·00844856051973·SET SCREW INSERTER-HL-R
HLR QUICK-FIT HEART-LUNG RESUSCITATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Hill-Rom
FDA UDI
Tridien Medical·00841965102848·Mattress, CMP EU HLR label
HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100
FDA 510(k)
FDA Class 2
·Cardiovascular
DASH 4000
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code DRT·October 26, 2007
ENTERPRISE 8000
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH MEDICAL BEDS DIVISION·Product code FNL·April 16, 2012
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·March 30, 2026
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·March 30, 2026
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·March 30, 2026
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·March 30, 2026
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·March 30, 2026
E-Z CLN PNL RKR MOD BD HLR BNS
FDA Adverse Event
Injury
·MEGADYNE MEDICAL PRODUCTS, INC.·Product code GEI·October 14, 2021
E-Z CLN PNL BTN MOD BD HLR BNS
FDA Adverse Event
Malfunction
·MEGADYNE MEDICAL PRODUCTS, INC.·Product code GEI·March 27, 2024
THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·July 23, 2024
AMVIA SKY DR-T
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVZ·May 27, 2025
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·March 3, 2026
Keratoscope, Battery-Powered
FDA classification
FDA Class 1
·Keratoscope, Battery-Powered
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
CLR MEDICAL, INC.
FDA registration
CLR MEDICAL, INC.·2 products·🇺🇸 United States