11 results
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26ms
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Sources: EU EUDAMED, US FDA
SURGICAL MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ERA® Implant Abutment Micro 0°, 5.5mm Cuff (AE)
FDA UDI
STERNGOLD DENTAL LLC·00841549106545·Implant retained overdentures are an establishe...
EARLOGIC OAE TESTER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES
FDA 510(k)
FDA Class 2
·Cardiovascular
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 2, 2015
ACCU-CHEK ® AVIVA
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code NBW·August 24, 2010
Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012
Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012
Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012
Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code FYD·June 8, 2012