11 results · 24ms · Sources: EU EUDAMED, US FDA

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Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)

FDA 510(k)
FDA Class 2 ·Neurology

SYRINGE 0.5CCM 30GA 8MM BLS 100BX/500 AP

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 2, 2019

DRG QUICKMIX

FDA 510(k)
FDA Class 2 ·Neurology

TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES

FDA 510(k)
FDA Class 2 ·General Hospital

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

PUMP MMT-715NAP PRDGM INS V2.1 PL EN

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·October 23, 2008

ASR UNI FEMORAL IMPL SIZE 46

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 10, 2011

2.4MM X-LOCK STD BLADE

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code GFA·July 8, 2013

Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 15, 2021