8 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PERACIDIN DIALYZER REPROCESSING CONCENTRATE
FDA 510(k)
FDA Class 2
·General Hospital
LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
FDA 510(k)
FDA Class 1
·Microbiology
DMS 300-2, 300-3 AND 300-4
FDA 510(k)
FDA Class 2
·Cardiovascular
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267A; 5) ECONO STERILE SENN RETR DE SH 6.25"STRLCS/25, Model Number 96-2269A; 6) ECONO STERILE MINI HOHMANN 6MM 6.5" STERCS25, Model Number 96-2959; retractors
FDA Enforcement
Class II
·Ongoing·Sklar Instruments·January 22, 2025
SM304 M-SERIES W/ZOOM
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIVISION·Product code INK·December 22, 2010
13.0MM REAMER HEAD-STERILE FORREAMER/IRRIGATOR/ASPIRATOR
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTO·February 15, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 11, 2014
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267A; 5) ECONO STERILE SENN RETR DE SH 6.25"STRLCS/25, Model Number 96-2269A; 6) ECONO STERILE MINI HOHMANN 6MM 6.5" STERCS25, Model Number 96-2959; retractors
FDA Recall
Open, Classified
·Sklar Instruments·Product code GAD·December 3, 2024