19 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Oticon
FDA UDI
Oticon A/S·05707131285997·NERA2 PRO TI, RITE 312 WL STG
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120465·Guidewire 0.9x150mm Dbl Trocar
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100035·BARRAQUER HEAVY WIRE SPECULUM LARGE
Fixed Reference Femoral Sizer
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215073725·
CARESTREAM IMAGE SUITE
FDA 510(k)
FDA Class 2
·Radiology
LADY COMP USA
FDA 510(k)
FDA Unclassified
·Unknown
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES GRENCHEN·Product code HRS·January 30, 2017
HYPERBARIC VENTILATOR
FDA Adverse Event
Malfunction
·SECHRIST INDUSTRIES, INC.·Product code CBK·August 15, 2016
HYPERBARIC VENTILATOR
FDA Adverse Event
Malfunction
·SECHRIST INDUSTRIES, INC.·Product code CBK·September 13, 2016
HYPERBARIC VENTILATOR
FDA Adverse Event
Malfunction
·SECHRIST INDUSTRIES, INC.·Product code CBK·February 21, 2017
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011
WOUND DRAIN
FDA Adverse Event
Injury
·PRODUCTOS PARA EL CUIDADO DE LA SALUD·Product code GBX·May 31, 2013
HEART RATE RESPIRATION MONITOR
FDA Adverse Event
Malfunction
·CAS MEDICAL SYSTEMS, INC.·Product code FLS·August 29, 2008
HYPERBARIC VENTILATOR
FDA Adverse Event
Malfunction
·SECHRIST INDUSTRIES, INC.·Product code CBK·December 6, 2016
HYPERBARIC VENTILATOR
FDA Adverse Event
Malfunction
·SECHRIST INDUSTRIES, INC.·Product code CBK·March 17, 2017
THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿
FDA Enforcement
Class II
·Terminated·Ameditech Inc·November 25, 2015
BIODESIGN OTOLOGIC REPAIR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH·Product code KHJ·January 11, 2018
HYPERBARIC VENTILATOR
FDA Adverse Event
Malfunction
·SECHRIST INDUSTRIES, INC.·Product code CBK·November 2, 2016