11 results · 26ms · Sources: EU EUDAMED, US FDA

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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