510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Ocular Instruments, Inc.

Bellevue, WA, US

OCULAR INSTRUMENTS, INC. appears in FDA device records in Bellevue, WA. FDA records list 50 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
50
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 50 510(k) clearances for Ocular Instruments, Inc. between 1984 and 2002. The busiest year on record is 1986, with 12. The most recent is 2002, with 1.

Clearances by year, as a table
510(k) clearance decisions for Ocular Instruments, Inc., by decision year
YearClearances
19841
19851
198612
19877
19885
19896
19901
19919
19922
19944
20011
20021
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K014170STAURENGHI WIDE FIELD SCANNING LASER LENSHJKSubstantially Equivalent
K012096DISPOSABLE VITRECTOMY LENSHJKSubstantially Equivalent
K933976MANDELKORN SUTURE LYSIS LENSHJKSubstantially Equivalent
K933264RITCH NYLON SUTURE LASER LENSHJKSubstantially Equivalent
K94142050 DEGREE HRI PRISM LENSHJKSubstantially Equivalent
K935302OSHER SURGICAL GONIO/POSTERIOR POLE LENSHKSSubstantially Equivalent
K923670BYRNE EXPULSIVE LENSHJISubstantially Equivalent
K921414TROKEL /3 GONIO LASER LENSLQJSubstantially Equivalent
K914051PEDIATRIC VITRECTOMY LENS SETHJKSubstantially Equivalent
K914117LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SETHJKSubstantially Equivalent
K910828LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESISMLPSubstantially Equivalent
K912269LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RINGHNHSubstantially Equivalent
K912268LANDERS NOTCHED VITRECTOMY LENS RINGHNHSubstantially Equivalent
K912253LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RINGHQESubstantially Equivalent
K912151LANDERS THREE STRUT VITRECTOMY LENS RINGHNHSubstantially Equivalent
K912366MAINSTER HIGH MAGNIFICATION LASER LENSHJKSubstantially Equivalent
K910231NMR-K FUNDUS LASER LENSHJKSubstantially Equivalent
K902496LANDERS VITRECTOMY LENS RING W/INFUSIONHNHSubstantially Equivalent
K896198MAINSTER WIDE FIELD LASER LENSHJKSubstantially Equivalent
K895846TWO MIRROR GONIO LENSHKSSubstantially Equivalent
K895013COBO TEMPORARY KERATOPROSTHESISMLPSubstantially Equivalent
K894421WOLDOFF PRISMATIC BICONCAVE LENSHJKSubstantially Equivalent
K893731SHIELDS T.C. LASER LENSLQJSubstantially Equivalent
K890977MCINTYRE SURGICAL GONIOLENSHKSSubstantially Equivalent
K882574BOLDREY PERIPHERAL RETINAL LENSLQJSubstantially Equivalent
K875331BICONCAVE VITRECTOMY LENSHJKSubstantially Equivalent
K875330HOSKINS-BARKAN GONIOTOMY LENS 10MMHJKSubstantially Equivalent
K875114HOSKINS-BARKAN GONIOTOMY LENS 9MMHJKSubstantially Equivalent
K875087PEYMAN G. 12.12 YAG LASER LENSHJKSubstantially Equivalent
K874220OCS 100 (OCULAR COMPARATOR SYSTEM)HJOSubstantially Equivalent
K87285518MM PEYMAN WIDE FIELD YAG LASER LENSHJKSubstantially Equivalent
K872802TROKEL SINGLE MIRROR YAG LASER LENSLQJSubstantially Equivalent
K87213612.5MM PEYMAN WIDE FIELD YAG LASER LENSHJKSubstantially Equivalent
K87145025MM PEYMAN WIDE FIELD YAG LASER LENSHJKSubstantially Equivalent
K871646TANNE CORNEAL CUTTING BLOCKHNJSubstantially Equivalent
K871099SCHIRMER NYLON SUTURE LASER LENSLQJSubstantially Equivalent
K864304YANNUZZI FUNDUS LASER LENSHJKSubstantially Equivalent
K863911MAINSTER RETINA LASER LENSHJKSubstantially Equivalent
K864418LANDERS INDIRECT VITRECTOMY LENSHJKSubstantially Equivalent
K863027SCHIRMER PERIPHERAL IRIDECTOMY LASER LENSHJKSubstantially Equivalent
K862869PETRUS SINGLE MIRROR LASER LENSLQJSubstantially Equivalent
K862868ABRAHAM YAG LASER LENSHJKSubstantially Equivalent
K862728HOSKINS NYLON SUTURE LASER LENSHJKSubstantially Equivalent
K862713ABRAHAM IRIDECTOMY LENS (YAG LASER)HKSSubstantially Equivalent
K862692KARICKHOFF DIAGNOSTIC/LASER LENSHKSSubstantially Equivalent
K862512RITCH TRABECULOPLASTY LASER LENSHKSSubstantially Equivalent
K862024SUSSMAN FOUR MIRROR HAND HELD GONIOPRISMHKSSubstantially Equivalent
K861648WISE IRIDOTOMY-SPINCTEROTOMY LENSHJKSubstantially Equivalent
K850991LANDERS VITRECTOMY LENS RING SYSTEMSHNHSubstantially Equivalent
K842856LANDERS-FOULKS TEMP. KERATOPROSTHESISMLPSubstantially Equivalent

Registered establishments

FDA registered establishments for Ocular Instruments, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30148653014865OCULAR INSTRUMENTS, INC.2255 116TH AVE., N.E., BELLEVUE, WA 98004 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain