8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Snowden-Pencer
FDA UDI
CAREFUSION 2200, INC·10885403048128·Snowden-Pencer Plastics DISSECTOR 13" (33CM)
V-TREND KIT STAPH LATEX TEST
FDA 510(k)
FDA Class 1
·Microbiology
TRI-STAGE (TS-I) DENTAL IMPLANT
FDA 510(k)
FDA Class 2
·Dental
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 19, 2014
SOFTCLIX® LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·October 28, 2010
8-10MM STARTER/SIZER AWL
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·December 18, 2012
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020