15 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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