16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780361855·Integra® Miltex® Knapp Iris Scissors 4-1/8", Cu...
Origin 125º Short Neck Collared Hip Stem
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215024161·
CEROS TCP GRANULES
FDA 510(k)
FDA Class 2
·Dental
NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE
FDA 510(k)
FDA Class 2
·Radiology
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·July 28, 2025
DHS®/DCS® COMPRESSION SCREW 36MM
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 17, 2014
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Malfunction
·WAVELIGHT GMBH·Product code LZS·July 6, 2011
LOFRIC PRIMO MALE
FDA Adverse Event
Injury
·WELLSPECT HEALTHCARE·Product code GBM·June 14, 2013
SHOULDER SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·October 8, 2025
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 10, 2021
DEKA MOTUS AY
FDA Adverse Event
Injury
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 18, 2019
KIT BD MAX ENTERIC VIRAL PANEL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code PCH·October 3, 2022
REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL NON-LOCKING SCREW - L46
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·July 27, 2022
REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·March 9, 2021
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021