17 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALL-BOND UNIVERSAL SC (NOT FINALIZED)
FDA 510(k)
FDA Class 2
·Dental
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131734·MUA AngBase RP
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
VISIONSCOPE HIGH DEFINITION ENDOSCOPY CAMERA SYSTEM WITH; CAMERA CONTROL UNIT; CAMERA HANDPIECE; VISIONSCOPE ENDOSCOPES
FDA 510(k)
FDA Class 2
·Orthopedic
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 20, 2015
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 29, 2016
DEXCOM G7 15 DAY CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 15, 2026
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 24, 2016
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 29, 2013
ATTAIN COMMAND
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DQY·June 16, 2011
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019
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