26 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UTF STEM, REDUCED
FDA 510(k)
FDA Class 2
·Orthopedic
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169606647·SPACER 2123550 O25 23.5MM 18 DEG 16X50
Atoll™
FDA UDI
Seaspine Orthopedics Corporation·10889981052461·3.5mm x 50mm Poly Screw Assm. The Atoll OCT Spi...
Sochi
FDA UDI
Altus Spine, LLC·00843210166575·Polyaxial Screw, 3.5mm x 50mm
WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
YOBOSHI DENTAL UNIT
FDA 510(k)
FDA Class 1
·Dental
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·May 18, 2026
KANGAROO
FDA Adverse Event
Injury
·CARDINAL HEALTH 200, LLC·Product code KNT·April 6, 2026
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·April 17, 2026
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·May 1, 2026
TINBN VANGUARD INT PS ANAT FM R 65MM
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·March 7, 2025
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 26, 2014
BIVONA TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·June 9, 2011
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·February 5, 2026
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·December 30, 2024
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019
INSTINCT JAVA SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER SPINE·Product code MNH·October 30, 2019