12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MOBICATH BI-DIRECTIONAL GUIDING SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
GYRUS ACMI, INC
FDA UDI
Gyrus ACMI, LLC·00821925015685·HOUSE TYPE INSTRUMENT CASE STAINLESS STEEL
HEANEY NEEDLE HOLDER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896099081·HEANEY NEEDLE HOLDER
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970355·
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD BC
FDA Adverse Event
Injury
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 6, 2019
QUATERA 700 BIMANUAL I/A HANDPIECE SET
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (OBERKOCHEN)·Product code FSO·September 8, 2023
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 24, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·September 30, 2014
UNKNOWN ZIMMER HIP
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWY·June 14, 2011
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019