12 results
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18ms
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Sources: EU EUDAMED, US FDA
X-RAY DETECTABLE THREAD
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Temena
FDA UDI
Temena GmbH·03700339712205·Epidural needle 18G x 120 mm
VariAx
FDA UDI
Stryker GmbH·37613154583318·BONE SCREWS,CROSS-PIN,SELF-T
Temena
FDA UDI
Temena GmbH·03700339710560·Kit for peripheral nerve blocks
BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SMART READ EZTEST STEAM
FDA 510(k)
FDA Class 2
·General Hospital
MAGNUM TRISPIKE CUP 56ODX50ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 15, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 31, 2012
5MM, 33CM ENDO METZENBAUM SCISSORS (CURVED)
FDA Adverse Event
Injury
·STRYKER ENDOSCOPY SAN JOSE·Product code LRW·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