10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMR TT Augmented Glenoid System
FDA 510(k)
FDA Class 2
·Orthopedic
THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
FDA 510(k)
FDA Unclassified
·Unknown
WATERLASE MD, MODEL 7100102
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FUJIFILM DUODENOSCOPE MODEL ED-580T
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDT·September 5, 2023
FUJIFILM ENDOSCOPE
FDA Adverse Event
Malfunction
·FUJIFILM CORPORATION·Product code FDS·March 18, 2022
FUJIFILM DUODENOSCOPE ED-580T
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDT·March 5, 2025
ETS LINEAR CUTTER
FDA Adverse Event
Death
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 22, 2014
UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM (FULL SYSTEM)
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·June 26, 2013
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·August 4, 2011
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016