8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage)
FDA 510(k)
FDA Class 2
·Orthopedic
PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW
FDA 510(k)
FDA Class 1
·General Hospital
ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
THERAPY ABLATION CATHETER
FDA Adverse Event
Malfunction
·IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY·Product code OAD·August 25, 2010
SOFTCLIX PLUS LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·November 14, 2008
MX-PRO R-3 AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·July 19, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·July 18, 2013
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