13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)
FDA 510(k)
FDA Class 2
·Microbiology
Orthocryl®
FDA UDI
DENTAURUM GmbH & Co.KG·J011161227000·Orthocryl® liquid "Somno pink"
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
FDA 510(k)
FDA Unclassified
·Unknown
BACK-TEK
FDA 510(k)
FDA Class 2
·Physical Medicine
ALERE DETERMINE HIV-1/2 AG/AB COMBO
FDA Adverse Event
Malfunction
·ALERE SCARBOROUGH, INC.·Product code MZF·October 19, 2017
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·December 20, 2010
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·February 13, 2017
ACCU-CHEK D-TRONPLUS
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·November 12, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008
RIBFIX BLU SYSTEM 12 HOLE PRE-BENT PLATE
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·January 5, 2021
RIBFIX BLU SYSTEM SCREW, SELF-DRILLING, CANCELLOUS X-DRIVE LOCKING 2.4 X 10MM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·January 5, 2021
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 20, 2017