16 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RHS
FDA 510(k)
FDA Class 2
·Orthopedic
MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER
FDA 510(k)
FDA Class 2
·General Hospital
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 14, 2019
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 4, 2019
NAVLOCK UNIVERSAL GREEN TRACKER
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·October 30, 2015
SCREW DRIVER
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·August 5, 2019
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 10, 2013
PEPGEN P-15
FDA Adverse Event
Injury
·DENTSPLY TULSA·Product code NPZ·June 12, 2008
UNICEL DXI WASH BUFFER II
FDA Adverse Event
BECKMAN COULTER INC.·Product code JJE·April 17, 2011
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·May 18, 2018
NAV THORACIC PROBE TIP
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC.·Product code OLO·August 27, 2014
TAMPONADE URETERINE BALLOON CATHETER SET
FDA Adverse Event
Injury
·COOK UROLOGICAL·Product code KNA·October 16, 2007
NEUROLOGICAL STEREOTAXIC INSTRUMENT
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·October 26, 2015
Instructions For Use document of the GPS Trackers.
FDA Enforcement
Class II
·Terminated·Blue Ortho·November 4, 2020