11 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LOMEFLOXACIN, 10 MCG, SENSI DISC
FDA 510(k)
FDA Class 2
·Microbiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123076·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 75mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471155992·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 230mm
FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm
FDA 510(k)
FDA Class 2
·Orthopedic
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 28, 2022
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·November 4, 2019
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·January 17, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 9, 2010
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2014
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025