26 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SpineNet SSP System
FDA 510(k)
FDA Class 2
·Orthopedic
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000889661·PLATE 7200170 ATL VISION ELITE 70MM
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994625021·PLATE 7200170 ATL VISION ELITE 70MM
DEBAKEY FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060357·DEBAKEY FORCEPS MICROSCOPIC ROUND HANDLE COUNTE...
Nanoplasty System
FDA UDI
Treace Medical Concepts, Inc.·00810111222402·Drill Guide
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114018·HYDRO-DISSECT FLAT J 25GA (PK/10)
RIVA Pedicle Screw System
FDA UDI
XENIX MEDICAL LLC·00840493419169·PRECONTOUR ROD, 6.0mm x 170mm
SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP
FDA 510(k)
FDA Class 2
·Orthopedic
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·June 10, 2002
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·December 29, 2005
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·September 9, 2008
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 28, 2025
OT ULTRA2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE GMBH·Product code NBW·July 17, 2019
SMARTSCREW
FDA Adverse Event
Other
·CONMED LINVATEC BIOMATERIALS LTD.·Product code MAI·October 1, 2008
CAPSUREFIX
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 10, 2011
UNK
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·July 1, 2013
TRUETRACK
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·August 17, 2018
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·November 15, 2022
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·April 3, 2018