151 results
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40ms
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Sources: EU EUDAMED, US FDA
Logicon Caries Detector
FDA UDI
G. A Industries·00868430000010·Logicon Caries Detector is a software tool for ...
Logicon Caries Detector
FDA UDI
G. A Industries·00868430000027·Logicon Caries Detector is a software tool for ...
Logicon Caries Detector
FDA UDI
G. A Industries·00868430000003·Logicon Caries Detector is a software tool for ...
JACKSON PRATT DRAIN
FDA Adverse Event
Injury
·DAVOL, INC.·Product code GCY·January 5, 1996
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 20, 2023
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 Recall
Terminated
·GA Industries·Product code MYN·April 6, 2015
INTROCAN SAFETY
FDA Adverse Event
Other
·B. BRAUN MEDICAL, INC.·Product code FOZ·July 11, 2008
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 9, 2025
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 9, 2025
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C; 5) DRAWER 4 - SUMMIT, REF ACC010627; 6) DRAWER 3, REF ACC010898.
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 9, 2025
SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRICATH FOLEY
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZC·December 27, 2018
SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRICATH FOLEY
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZC·December 21, 2018
ERAGON BIPOLAR
FDA Adverse Event
Malfunction
·RICHARD WOLF GMBH·Product code HET·August 12, 2020
ERAGON BIPOLAR
FDA Adverse Event
Malfunction
·RICHARD WOLF GMBH·Product code HET·June 29, 2020
ERAGON BIPOLAR
FDA Adverse Event
Malfunction
·RICHARD WOLF GMBH·Product code HET·June 29, 2020
BARDEX ALL-SILICONE TEMPERATURE-SENSING FOLEY CATHETER
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZL·May 27, 2020
BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZL·June 12, 2019
BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code MJC·February 15, 2019
BARDEX® ALL-SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZL·January 11, 2019
BARDEX® ALL-SILICONE FOLEY CATHETER
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZL·February 14, 2019