19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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S9 WANDA VPAP ST
FDA 510(k)
FDA Class 2
·Anesthesiology
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973646·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973561·
SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
APM BLOOD PRESSURE MONITOR, MODEL BP108A
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 18, 2023
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 20, 2020
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 10, 2020
CONTOUR TS
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·October 6, 2009
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 26, 2022
MUSTANG?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 24, 2025
ACCU-CHEK ACTIVE TEST STRIPS
FDA Adverse Event
Malfunction
·RROCHE DIAGNOSTICS·Product code LFR·October 24, 2008
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 15, 2021
GLUCOMETER ELITE 4 BASIC
FDA Adverse Event
Other
·ARKRAY, INC.·Product code NBW·March 19, 2003
MAXISKY 600
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH MAGOG INC.·Product code FNG·May 24, 2013
SYNCHRON® SYSTEMS RHEUMATOID FACTOR (RF) REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHR·June 25, 2011
PFNA-II Ø10 LONG LE 125° L320 TAN
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code JDS·October 3, 2014
MUSTANG
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·May 2, 2025
Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·May 16, 2018