24 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LMA FAMILY OF AIRWAYS
FDA 510(k)
FDA Class 1
·Anesthesiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699564·GENUMEDI PSS BLUE, SIZE IV
CoRoent
FDA UDI
Nuvasive, Inc.·00887517565112·CoRoent Ant TLIF PEEK, 13x10x30mm 4°
ArgenZ HT+ 98x12 ML C3B
FDA UDI
ARGEN CORPORATION, THE·D818130304·Dental porcelain/ceramic restoration kit
EVONOS GMBH & Co. Kg
FDA UDI
Gyrus ACMI, LLC·00821925012622·SCHEER CURETTE 25 DEGREE CUP ANGLE 2.41 MM X 1....
K2M General Instruments
FDA UDI
VB Spine LLC·10888857559929·Right Angled Serrated Curette Bayoneted Size #3
APEX ER. YAG / IPL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ST AIA PACK HBA1C
FDA 510(k)
FDA Class 2
·Hematology
M-SERIES
FDA UDI
Savaria Concord Lift·10688503000870·Patient lifter
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 3, 2023
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code LZG·November 14, 2016
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
HANDLE CEV669B DIA 5MM ANG BIPOLAR [MXI/XOM]
FDA Adverse Event
Malfunction
·XOMED MICROFRANCE MFG·Product code GEI·September 24, 2013
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·SMALL BONE INNOVATIONS, INC.·Product code NTG·June 20, 2014
ADULT HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·August 29, 2013
AIRVO2 HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 18, 2016
HANDLE CEV669B DIA 5MM ANG BIPOLAR [MXI/XOM]
FDA Adverse Event
Malfunction
·XOMED MICROFRANCE MFG·Product code GEI·September 13, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 24, 2013
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·May 9, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 22, 2008