12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEOSS PROACTIVE TAPERED IMPLANT
FDA 510(k)
FDA Class 2
·Dental
QFLOW 500 PERFUSION MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 15, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 9, 2025
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 15, 2013
ASR ACETABULAR IMPLANT 54
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·May 20, 2011
1.55MM X 10MM FLUTED TWIST DRL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016
1.55MM X 10MM FLUTED TWIST DRL
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2016
VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·February 19, 2020
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021