13 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EXTRACORPOREAL BLOOD GAS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
OPHTHALMED LLC·M735A8220001·
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564039149·L4 PREM SPEC GWN MED W/PAP TWL
Stradis Medical, LLC.
FDA UDI
STRADIS MEDICAL, LLC·M75268220001·Donners and Gloves
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690117827·Modular Tibia Torque Control Handle
ResQPOD ITD 16
FDA UDI
Zoll Medical Corporation·00847946026943·RESQPOD ITD 16, US
POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNKNOWN HIP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 20, 2014
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·October 1, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 1, 2010
RESTYLANE DEFYNE
FDA Adverse Event
Injury
·Q-MED·Product code LMH·June 15, 2023
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018