7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 8, 2013
DERMABOND ADVANCED TOPICAL SKIN ADHESIVE
FDA Adverse Event
Injury
·ETHICON INC.·Product code MPN·August 8, 2014
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
FDA Adverse Event
STAAR SURGICAL CO.·Product code HQL·February 8, 2011
LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.
FDA Enforcement
Class II
·Terminated·Cook Inc.·July 1, 2015