9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ELVI ACID & PROSTATIC PHOSPHATASE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Image Guidance System for Radiotherapy
FDA 510(k)
FDA Class 2
·Radiology
MAMMOSITE MULTI LUMEN
FDA 510(k)
FDA Class 2
·Radiology
MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH
FDA Adverse Event
Malfunction
·SIRONA DENTAL SYSTEMS GMBH·Product code EFB·April 20, 2023
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·January 27, 2023
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 2, 2014
LIGACLIP** MCA CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDO·October 16, 2012
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2010
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018