21 results
·
31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017442·Hook Punch set down 2.7mm 30 degree left
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017459·Hook Punch set down 3.5mm 30 degree left
OMNIA X/XS ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SPINEWAND SURGICAL DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·October 8, 2018
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING INC·Product code JGJ·May 20, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·June 10, 2011
MONOSYN UNDYED 5/0 OR 6/0
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·June 23, 2021
MONOSYN UNDYED 5/0 OR 6/0
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·June 23, 2021
MONOSYN UNDYED 5/0 OR 6/0
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·June 23, 2021
MONOSYN UNDYED 5/0 OR 6/0
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·June 23, 2021
MONOSYN UNDYED 5/0 OR 6/0
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·June 23, 2021
MONOSYN UNDYED 5/0 OR 6/0
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·June 23, 2021
MONOSYN UNDYED 5/0 OR 6/0
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·June 23, 2021
MONOSYN UNDYED 5/0 OR 6/0
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·June 23, 2021
MONOSYN UNDYED 5/0 OR 6/0
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·June 23, 2021
MONOSYN UNDYED 5/0 OR 6/0
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·June 23, 2021
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