10 results
·
28ms
·
Sources: EU EUDAMED, US FDA
PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·10884450268176·
HEMA SCREEN ER
FDA 510(k)
FDA Class 2
·Hematology
STERISHARP 3-GALLON RSDC, MODEL RSDC3G
FDA 510(k)
FDA Class 2
·General Hospital
GALAXY G3 MINI 2MM X 6CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·October 23, 2020
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·May 20, 2013
SYNCHRON LX I 725 CLINICAL SYSTEM
FDA Adverse Event
Other
·BECKMAN COULTER, INC.·Product code MMI·August 14, 2008
ARMADA 14 PTA CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LIT·June 10, 2011
23G POSTERIOR PROCEDURAL PACK WITH WF
FDA Adverse Event
Malfunction
·BAUSCH + LOMB·Product code HQC·February 6, 2019
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015