11 results
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18ms
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Sources: EU EUDAMED, US FDA
GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)
FDA 510(k)
FDA Class 2
·Microbiology
Bioplate®
FDA UDI
Bioplate, Inc.·M3848120781·Self-Drilling Screw - Ø1.9 mm x 6 mm [5 PK]
Bioplate®
FDA UDI
Bioplate, Inc.·M384812078US1·Self-Drilling Screw - Ø1.9 mm x 6 mm [5 PK]
ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)
FDA 510(k)
FDA Class 2
·Dental
RADIOFIX
FDA 510(k)
FDA Class 2
·Orthopedic
MINI-INFUSER RADIATION STERILIZED EXTENSION SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 7, 2021
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 15, 2014
REVO MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWP·October 31, 2012
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2010
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 9, 2015
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