22 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Brainomix 360 e-CTP
FDA 510(k)
FDA Class 2
·Radiology
Wrist Lacer
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357235551·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694021463·FPS 3.5mm x 55mm Locking Screw
Sklar®
FDA UDI
SKLAR CORPORATION·10649111312359·ROCH PEAN STR DEL 5 1/2"
OsteoMed
FDA UDI
OSTEOMED LLC·00845694075961·FPS 3.5 x 55mm Locking Screw Sterile Qty 2
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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
JUVEDERM VOLUMA WITH LIDOCAINE 1 ML
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·October 29, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011
SET SCREWDRIVER, FLEXIBLE SHAFT 4 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-KIEL·Product code LXH·July 12, 2013
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·February 5, 2026
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·December 30, 2024
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·November 25, 2025
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025