9,276 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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HLL LIFECARE LIMITED
FDA registration
HLL LIFECARE LIMITED·1 product·🇮🇳 India
BETA TITANIUM™
FDA UDI
ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC·00810042122345·Nickel Free Archwires Natural Form .018 x .025 ...
HILROM
FDA Adverse Event
Injury
·HLL-ROM·Product code FNJ·January 29, 1999
MyoSleeve
FDA UDI
ELASTIMED LTD·07290020483058·MyoSleeve
Half leg, Large, Left, Short
MyoSleeve
FDA UDI
ELASTIMED LTD·07290020483041·MyoSleeve
Half leg, Large, Right, Short
HLL-ROM 100 LOW BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·August 9, 2010
VANTAGE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code HSN·May 13, 2025
ADVANTA 2
FDA Adverse Event
Malfunction
·HLL-ROM DE MEXICO S DE RL DE CV·Product code FNL·July 19, 2012
Monitor, Eye Movement
FDA classification
FDA Class 2
·Monitor, Eye Movement
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
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
SS Crown 3LL
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199001220·
ROC Crown 3LL
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199001530·
SS Crown 2LL
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199001210·
SS Crown 4LL
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199001230·
ROC Crown 4LL
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199001540·
Hill Laboratories
FDA registration
Hill Laboratories·9 products·🇺🇸 United States
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
TrueCare Biomedix
FDA UDI
U.S. Infusion, LLC·10850789007342·