26 results · 22ms · Sources: EU EUDAMED, US FDA

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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