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

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Blood Pressure Monitor

FDA 510(k)
FDA Class 2 ·Cardiovascular

Wrist Lacer II

FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357233748·

IMP,TSV,3.7,13,MTX,MG

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·August 3, 2020

GROSHONG NXT DUAL LUMEN PICC CATHETERS

FDA 510(k)
FDA Class 2 ·General Hospital

X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)

FDA 510(k)
FDA Class 2 ·Dental

4.7 X 13 IMPLANT

FDA Adverse Event
Injury ·BIOMET 3I·Product code DZE·August 3, 2020

IMP,TSV,3.7,13,MTX,MG

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·October 16, 2020

IMP,TSV,3.7,13,MTX,MG

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·July 30, 2019

NEXGEN TM TIBIAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code MBH·October 29, 2014

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

OT PING ENHANCED METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013

IMP,TSV,3.7,13,MTX,MG

FDA Adverse Event
Malfunction ·ZIMMER DENTAL·Product code DZE·November 23, 2022

Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

FDA Enforcement
Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

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

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

SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

FDA Enforcement
Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018