11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
DAILIES TOTAL 1
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code LPL·August 3, 2012
DAILIES TOTAL 1
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·July 19, 2012
DAILIES TOTAL 1
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·November 9, 2012
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984273·anteriors; shade B2; mould O 48
NIDEK MODEL AKC-8000
FDA 510(k)
FDA Class 2
·Ophthalmic
MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RIATA ST OPTIM PASSIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013
COLLEAGUE PUMP CE ENGLISH VERSION
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 10, 2011
SYSTEM CONSOLE
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·December 18, 2013
UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D465-61Z, JD365-6033Z, DF370-6121Z, DF3110-61Z, DF375-17621Z, DF375-6121Z, DF475-17621Z, DF370-6121Z, DF375-6121Z, DF470-6021Z, D366-618Z, D390-60Z, D390-61Z, DP260-61, DF370-6121Z, D3120-6154Z, F95100, JD365-6033Z, DF370-61Z, DF475-61Z, DF3110-6121Z, DF3110-6121Z, DF375-6121Z, DF475-6121Z, F90755, F90798, F95368, PDP260-61, D396R-61Z, F90578, F90622Z, F94980, D360-61Z, D365-6121Z, D366-6121Z, D366-6121Z, SJDF3116-6121Z, DF375-6121Z, DF470-6121Z, DF470-61Z, DF475-6121Z, DF375-6033Z, DF375-618Z, DF470-6127Z, DF475-61Z, DF476-6121Z, F90756, PDB160-6131, PDP160-6121, PDY160-6121, D060-8021, D366-8021Z, D466-6121Z, DF370-6121Z, DF470-6121Z, DF376-6121Z, PDP160-6031, D360-8021Z, D360-80Z, D445-80Z, D465-8021Z, JD365-6033Z, D460-6131Z, D460-6133Z, DF475-6121Z, DF3116S-608Z, F90777, D360-6133Z, D365-80Z, D360-6021Z, D360-6121Z, D360-61Z, DF3110-61Z, DF370-61Z, DF375-17621Z, DF475-6121Z, D365-6121Z, D060-80, PD060-6121, PD160-6121Z, PDP160-6121, DF3115-6121Z, F90767, DF375-17621Z, DF375-6121Z, DF470-6121Z, PD260-61Z, PDY140-6133, D360-16421Z, D360-6121Z, D366-6121Z, DFP2110-6121, DF470-6121Z, D465-8021Z, DF4115-6121Z, DF370-6121Z, DF376-6121Z, PDB140-61, D365-6121Z, DF070-61, PDY160-6121, D365-61Z, D360-6121Z, D360-61Z, D460-6121Z, DF0110-6121, DF3110-61Z, DF370-61Z, DF375-6121Z, DF375-6121Z, DF475-6121Z, DF475-6121Z, DF370-6021Z, DF370-6133Z, DF375-618Z, DF475-17621Z, DFB170-61, PD040-61, PDP160-6121, PDY160-6121, D390-61Z, F94474, D460-61Z, D366-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, DF0110-61, DF0110-61, DF3115-6121Z, DF3115-6121Z, DF070-6127, F90752, DF375-17621Z, DF375-61Z, DF376-17621Z, F95100, D360-6021Z, D366-6121Z, D465-8021Z, D360-61Z, DF3110-61Z, DF3110-61Z, DF3110-6121Z, PDP160-6031, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D360-6121Z, D460-61Z, D3120-6121Z, D360-8021Z, D365-80Z, D395-8021Z, D460-8021Z, D465-8021Z, D495-61Z, F90577Z, DF370-6133Z, DF375-6021Z, DF376-6121Z, DF475V-6121Z, DFP170-6121, DF370-61Z, DF470-6121Z, DF470-6121Z, DF470-6121Z, DF470-6121Z, DF470-61Z, DF3115-6121Z, F90767, DF370-6121Z, DF375-6121Z, DF476-6121Z, F95407, F90556, D365V-8021Z, F95383, D460-61Z, F90777, DF370-6121Z, DF370-6121Z, DF375-17621Z, DF475-6121Z, D440-80Z, D360-6021Z, D365-6121Z, DF370-61Z, DF4116-6121Z, DF476-6121Z, F90579, D345-6121Z, D396R-61Z, D460-80Z, D465-6031Z, D465-8021Z, DP2120-61, F90578, F94795, F94980, D360-61Z D365-6121Z, D365-6121Z, D366-6121Z, D366-6121Z, D460-6121Z, D460-6121Z, D460-61Z, D360-6021Z, D360-6121Z, D366-6121Z, D366-6121Z, D060-8021, D3120-6121Z, D360-16421Z, D360-8021Z, D360-8031Z, D366-80Z, D390-61Z, D460-80Z, D465-8021Z, D465V-8021Z, PDP160-6121, DF070-6121, DF370-6021Z, DF375-61Z, DF375-61Z, DF375-61Z, DF470-6021Z, DF475-61Z, DFY170-6121, DF375-17621Z, DF375-6121Z, DF375-6121Z, DF470-6121Z, DF475-6121Z, DF475-6121Z, SJDF3116-6121Z, DF3115-6121Z, DF3116-6121Z, DF4115-6121Z, DF4116-6121Z, DF475-6121Z, DF375-6121Z, DF375-6121Z, DF470-6121Z, DF0110-618, DF370-61Z, DF375-6121Z, DF475-6121Z, DF475-6121Z, DF375-6021Z, F90798, PDP140-6121, D365V-8021Z, D366-8021Z, D445-80Z, D460-8021Z, D460-8021Z, D465-61Z, D365-61Z, DF3116S-608Z, DF370-6121Z, DF375-17621Z, DF375-6121Z, DF470-6127Z, DF475V-6121Z, DF476-6121Z, F95368, F95407, PD060-61, PDB160-6131, PDP160-6121, D460-6131Z, D360-6121Z, D360-61Z, DF370-6121Z, DF375-17621Z, DF475-6121Z, DF376-17621Z, D3120-6121Z, D466-6121Z, DF4110-6121Z, DF370-6121Z, DF376-6121Z, DF475V-6121Z, D440-80Z, DF376R-61Z, DF0110-6121, DF370-6121Z, DF470-6121Z, DF375-17621Z, DF370-6021Z, DF475-61Z, DFP170-6121, DFY270-6121, PDP264C-61, D360-8021Z, D365-8021Z, D365-80Z, D365-80Z, F90578, D360-6121Z, D360-6121Z, D360-61Z, D460-6121Z, DF3115-6121Z, DF3115-6121Z, DF4115-61Z, DFP2110-61, DF375-6121Z, DF470-6121Z, DF475-6121Z, DF476-6121Z, DF470-6121Z, DF475V-6
FDA Enforcement
Class II
·Terminated·King Systems Corp. dba Ambu, Inc.·January 17, 2018