12 results
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23ms
·
Sources: EU EUDAMED, US FDA
SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131709·TiBase MA 3.0G NE
Pro-Link Ti
FDA UDI
Life Spine, Inc.·00190837080693·
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857561687·Trial Size 13x16x5 mm, 7 Deg.
FOUNDATION DENTAL RESIN
FDA 510(k)
FDA Class 2
·Dental
LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 29, 2013
ENTRUST AT
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·June 16, 2011
VERSAFITCUP CC HIGHCROSS PE LINER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·October 18, 2013
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015