FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K160710 |
ANODYNE |
Oasis Lacrimal Intubation Set |
05/13/2016 |
K113508 |
ARMADILLO BIOMEDICAL, LLC |
DACRYOCATH |
08/31/2012 |
K142914 |
ARMADILLO BIOMEDICAL, LLC |
DacryoCATH |
01/12/2015 |
K973872 |
ATRION MEDICAL PRODUCTS, INC. |
ATRION MEDICAL COATED LACRIMAL INTUBATION SET |
01/08/1998 |
K973633 |
ATRION MEDICAL PRODUCTS, INC. |
ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET |
01/16/1998 |
K113316 |
DCS SURGICAL INC |
DCS LACRIMAL STENT |
11/08/2012 |
K030353 |
EAGLE VISION, INC. |
MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS |
04/25/2003 |
K161373 |
FCI (FRANCE CHIRURGIE INSTRUMENTATION) |
Nunchaku |
11/03/2016 |
K201606 |
FCI (France Chirurgie Instrumentation) SAS |
LacriJet« |
12/18/2020 |
K201892 |
FCI (France Chirurgie Instrumentation) SAS |
Ritleng«+ and Ritleng«+ PVP |
03/11/2021 |
K023758 |
FCI OPHTHALMICS, INC. |
BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) |
09/17/2003 |
K991238 |
FCI OPHTHALMICS, INC. |
FCI CRAWFORD PROBE INTUBATION SETS |
07/08/1999 |
K061404 |
FCI OPHTHALMICS, INC. |
MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE |
08/07/2006 |
K041869 |
FCI OPHTHALMICS, INC. |
SELF RETAINING BICANALICULUS INTUBATION SET |
11/18/2004 |
K121142 |
FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) |
CRAWFORD BIOCANALICULUS INTUBATION |
08/09/2012 |
K113536 |
FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) |
MASTERKA 40 MASTERKA 35 MASTERKA 30 |
08/03/2012 |
K130375 |
FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) |
SELF-RETAINING BICANALICULUS INTUBATON SET II |
12/04/2013 |
K123831 |
FRANCE CHIRURGAE INSTRUMENTATION |
OPHTACATH KIT |
07/29/2013 |
K955671 |
G.W.B. INTL., LTD. |
RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.) |
03/06/1996 |
K120886 |
HIROYASU HIGUCHI |
LACRIFAST |
12/17/2012 |
K990672 |
HURRICANE MEDICAL |
LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET |
05/18/1999 |
K170247 |
KANEKA PHARMA AMERICA LLC |
Lacriflow CL |
04/18/2017 |
K140290 |
LJT SURGICAL LTD |
STOPLOSS JONES TUBE |
12/02/2014 |
K012108 |
POREX SURGICAL, INC. |
MEDPOR COATED TEAR DRAIN |
12/19/2001 |
K113867 |
QUEST MEDICAL, INC. |
LACRICATH LACRIMAL DUCT CATHETER |
10/19/2012 |
K113118 |
QUEST MEDICAL, INC. |
STENTUBE LACRIMAL INTUBATION SET |
07/31/2012 |
K962151 |
RYDER INTL. CORP. |
RYDER LACRIMAL INTUBATIONSET |
09/18/1996 |