10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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URIC ACID TEST ITEM NUMBER 65422
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981202644·Interbody, 9mm x 32mm x 16mm, 20 deg
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981194659·Interbody, 9mm x 32mm x 16mm, 20 deg
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·May 25, 2020
DESARA
FDA Adverse Event
Injury
·CALDERA MEDICAL, INC.·Product code FTL·January 25, 2013
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS LLC·Product code MCM·December 6, 2010
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 14, 2014
Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410
FDA Enforcement
Class I
·Terminated·BioMedical Equipment Service Co (BMES)·August 18, 2021