17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Revitalair 430+
FDA 510(k)
FDA Class 2
·Anesthesiology
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540356659·SCREWDRIVER RATCHETING HANDLE
TOSHIBA 1.5T CARDIAC COIL
FDA 510(k)
FDA Class 2
·Radiology
DASH 3000/4000 PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
1220290-1999-00002
FDA Adverse Event
Injury
·Product code HQC·September 29, 1999
T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·May 2, 2018
AUTOSOFT 90
FDA Adverse Event
Malfunction
·Product code FPA·July 10, 2020
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·October 1, 2019
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 11, 2022
ILET BIONIC PANCREAS
FDA Adverse Event
Malfunction
·BETA BIONICS INC.·Product code QFG·January 6, 2026
RANAWAT/BURSTEIN ACETABULAR SHELL 54MM POROUS COATED
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·August 26, 2016
SOFTCLIX PLUS LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·November 3, 2008
GENDER SOLUTIONS NATURAL KNEE ART SURFACE
FDA Adverse Event
Injury
·ZIMMER INC·Product code JWH·August 16, 2011
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013
LOCKING SCREWS, SELF DRILLING, 2.0X8MM, 5/P
FDA Adverse Event
Malfunction
·STRYKER LEIBINGER FREIBURG·Product code DZL·September 4, 2018
MMF SCREWS,2.0X12MM, CROSS-PIN, SELF DRILLING, 4/P
FDA Adverse Event
Malfunction
·STRYKER LEIBINGER FREIBURG·Product code DZL·January 22, 2019
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018