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

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INCORIS TZI

FDA 510(k)
FDA Class 2 ·Dental

PIVOX™ Oblique Lateral Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169606630·SPACER 2123545 O25 23.5MM 18 DEG 16X45

Atoll™

FDA UDI
Seaspine Orthopedics Corporation·10889981052454·3.5mm x 45mm Poly Screw Assm. The Atoll OCT Spi...

SurgyCut

FDA UDI
U.S. SURGITECH INC.·00810014632698·SurgyCut Straight Blade with Suction & Electrod...

Sochi

FDA UDI
Altus Spine, LLC·00843210166568·Polyaxial Screw, 3.5mm x 45mm

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970577·

ULTRA-LITE 200E LIGHT CURE UNIT

FDA 510(k)
FDA Class 2 ·Dental

BT-350

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

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

FETAL MONITOR/CARDIOTOCOGRAM

FDA Adverse Event
Injury ·BISTOS CO., LTD.·Product code HGL·January 29, 2018

ROD, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019

5.5 TI CANNULATED TRANSLATION SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019

PENTA

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013

MINICAP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 26, 2014

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·Product code LZG·October 2, 2015

ILIAC SCREW, UNKNOWN SIZE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MNH·October 16, 2019

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·February 5, 2026