13 results · 27ms · Sources: EU EUDAMED, 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