13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTUITION - TDA, TVA, PARAMETRIC MAPPING
FDA 510(k)
FDA Class 2
·Radiology
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131447·MUA NC NP 1.5GH Str
CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G
FDA 510(k)
FDA Class 2
·Radiology
ZIMMER PERIARTICULAR SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code DTB·October 1, 2014
URETEX SUPPORT PP TRANSOBTUR2 KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·May 10, 2013
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 11, 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