2,412 results
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85ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMPACT APPLICATIONS, INC.
FDA registration
IMPACT APPLICATIONS, INC.·2 products·🇺🇸 United States
ImPACT Pediatric
FDA UDI
IMPACT APPLICATIONS, INC.·00864127000318·ImPACT Pediatric is intended for use as a compu...
ImPACT
FDA UDI
IMPACT APPLICATIONS, INC.·00864127000301·ImPACT is intended for use as a computer-based ...
ImPACT Quick Test
FDA UDI
IMPACT APPLICATIONS, INC.·00864127000325·ImPACT Quick Test is intended for use as a comp...
ImPACT Version 4
FDA UDI
IMPACT APPLICATIONS, INC.·00864127000349·ImPACT is intended for use as a computer-based ...
Cognitive Impairment Screener
FDA UDI
IMPACT APPLICATIONS, INC.·00864127000332·
ImPACT Quick Test
FDA UDI
IMPACT APPLICATIONS, INC.·00864127000356·ImPACT Quick Test is intended for use as a comp...
a. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25. b. DERMA SCIENCES, INC. Surgitube BANDAGE, GAUZE #2P 7/8"X50YDS DERSCI Catalog GL-242. c. DERMA SCIENCES, INC. Surgilast TUBE NET SZ3 MED 10YDS/EA HAND, ARM, LEG, FOOT SURGILAST Catalog # GL103. d. DERMA SCIENCES, INC. Surgitube & Surgigrip APPLICATOR, SURGITUBE/GRIP METAL SZ3 6" CHLD/ADLT DERSCI Catalog #GL-234.
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
TECNIS SIMPLICITY
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·April 20, 2021
TECNIS IOL
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·January 15, 2021
SENSAR IOL
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·September 14, 2021
SENSAR IOL
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·April 2, 2021
TECNIS IOL
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·September 20, 2021
HEALON ENDOCOAT
FDA Adverse Event
Malfunction
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LZP·March 20, 2018
TECNIS SYNERGY SIMPLICITY TORIC II
FDA Adverse Event
Injury
·AMO MANUFACTURING NETHERLANDS·Product code MFK·July 28, 2021
TECNIS IOL
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·January 27, 2021
TECNIS IOL
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·September 1, 2022
SINGLE-SITE
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·January 9, 2023
TECNIS SIMPLICITY
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·September 27, 2021
TECNIS SIMPLICITY
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·October 26, 2021