22 results · 24ms · Sources: EU EUDAMED, 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