8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BRUCELLA AGAR
FDA 510(k)
FDA Class 1
·Microbiology
Ambu® aScope Duodeno 2, Ambu® aBox 2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PERSEUS A500
FDA 510(k)
FDA Class 2
·Anesthesiology
OCTRODE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 5, 2012
UNKNOWN HIP LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·May 27, 2014
EDHICON MONOCRYL 3-0
FDA Adverse Event
Malfunction
·ETHICON·Product code MOF·May 21, 2015
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015
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