11 results
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18ms
·
Sources: EU EUDAMED, US FDA
SOF-TOUCH NASAL CANNULA CAT.#304 & 305
FDA 510(k)
FDA Class 1
·Anesthesiology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112557·BARRON VACUUM TREPHINE 9.0MM
wheezo WheezeRate Detector
FDA 510(k)
FDA Class 2
·Anesthesiology
SAMSUNG 10DR IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
PLUM A+ DRIVER NEW 8
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 4, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 23, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 16, 2010
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code HRH·May 3, 2013
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024