18 results · 37ms · Sources: EU EUDAMED, US FDA

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Ceramill A-Splint

FDA 510(k)
FDA Unclassified ·Unknown

NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK

FDA 510(k)
FDA Class 1 ·General Hospital

PERMASHADE VENEER CEMENT

FDA 510(k)
FDA Class 2 ·Dental

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 24, 2025

STEM: M-VIZION PROXIMAL BODY 20MM L 80MM STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 17, 2021

STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 19, 2022

QUICKFLEX XL LV LEAD

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·January 13, 2014

CS100

FDA Adverse Event
Malfunction ·DATASCOPE CORP·Product code DSP·July 29, 2011

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 26, 2013

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 29, 2025

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 27, 2025

M-VIZION PROXIMAL BODY HANDLE

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·March 28, 2024

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LZO·May 28, 2026

STEM: M-VIZION PROXIMAL BODY 20MM L 50MM LAT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 24, 2021

M-VIZION INSERTER ROD

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·May 28, 2024

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 16, 2025

Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Enforcement
Class I ·Terminated·Dexcom Inc·April 20, 2016

GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital radiographic images of the skull, spinal column, chest, abdomen, extremities and other body parts in patients of all ages.

FDA Enforcement
Class II ·Terminated·GE Healthcare, LLC·August 27, 2014