1,222 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODEL 1014 PC ELECTROMETER
FDA 510(k)
FDA Class 2
·Radiology
DELTA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252528999·DELTA 2.2MM PANEL 116x11x1.4MM
Titan™
FDA UDI
Ascension Orthopedics, Inc.·10381780243175·Titan™ Total Shoulder System
The Titan Modular ...
COLOR BUFFED (CB) DDH FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET
FDA 510(k)
FDA Class 2
·Cardiovascular
ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED
FDA Adverse Event
Injury
·ETHICON INC.·Product code KOG·July 7, 2015
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS LLC·Product code OYC·January 16, 2019
NUCLEUS CI522 COCHLEAR IMPLANT WITH SLIM STRAIGHT ELECTRODE
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·July 10, 2019
LINOX T 65
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·May 3, 2013
HIRES 90K ADVANTAGE IMPLANT
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·August 21, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 18, 2011
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·February 7, 2019
CONELOG SCREW LINE IMPLANT PROMOTE PLUS
FDA Adverse Event
Injury
·ALTATEC GMBH·Product code DZE·April 12, 2024
640G INSULIN PUMP MMT-1712K
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 18, 2022
BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number 8101403, and Biotrue ONEday 90 pack Carton International - Part Number 8098203.
FDA Enforcement
Class II
·Terminated·Bausch & Lomb Inc Irb·November 11, 2015
BIA400 IMPLANT 4MM W ABUTMENT 10MM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·July 8, 2019
BIA400 IMPLANT 4MM W ABUTMENT 10MM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·July 8, 2019
ARROW MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8"
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code FOZ·September 20, 2019
NUCLEUS FREEDOM IMPLANT WITH STRAIGHT ELECTRODE
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·October 2, 2019
BIA400 IMPLANT 4MM W ABUTMENT 10MM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·September 9, 2019