12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Eclipse with VEMP
FDA 510(k)
FDA Class 2
·Neurology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776115951·Slotted U Bracket
Avalign
FDA UDI
Avalign Technologies, Inc.·00190776023317·Slotted U Bracket
AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRIATHLON LOW PROFILE TIBIAL TRAY
FDA 510(k)
FDA Class 2
·Orthopedic
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
M2A 1 PC SHELL 38MMX60MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·December 11, 2017
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 6, 2013
UNKNOWN NEXGEN KNEE IMPLANT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·July 12, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·October 10, 2014
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014