19 results
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20ms
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Sources: EU EUDAMED, US FDA
PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN
FDA 510(k)
FDA Class 1
·Anesthesiology
Bioplate®
FDA UDI
Bioplate, Inc.·M3848120660·Self-Drilling Screw - Ø1.5 mm x 4 mm
Bioplate®
FDA UDI
Bioplate, Inc.·M384812066US0·Self-Drilling Screw - Ø1.5 mm x 4 mm
Bioplate®
FDA UDI
Bioplate, Inc.·M384812066CP1·Self-Drilling Screw - Ø1.5 mm x 4 mm
EZout
FDA UDI
STRYKER CORPORATION·07613327294514·Blade Pack, 66mm
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·February 4, 2021
8100 PUMP MODULE 9.1.17.7
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 17, 2021
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 15, 2021
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 28, 2021
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 12, 2021
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 7, 2021
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·May 15, 2014
CONSULTA CRT-D
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·August 18, 2010
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
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