ClearanceBrief
Panels › Ophthalmic › Product code OJK · Class 2

Eye Tray

Regulation 886.4790

0510(k)s in 12 months (0 all time)
17recalls in 12 months (74 all time)
0recalls that name a 510(k)
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Top companies in OJK

DateFirm and productCodeLinked 510(k)
Oct 15, 2026Medline Industries, LP
Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D
Open, Classified
OJKNone listed
Sep 16, 2026Medline Industries, LP
Convenience kits CATARACT PACK DYNJ59881A
Open, Classified
OJKNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A
Open, Classified
OJKNone listed
Aug 31, 2026Medline Industries, LP
Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number: DYKM2751A; 3) CATARACT PREOP KIT, Model Number: DYKS1583A; 4) CATARACT PREOP KIT, Model Number: DYKS1583B
Open, Classified
OJKNone listed
Aug 13, 2026Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catal
Open, Classified
OJKNone listed
Jul 20, 2026AVID Medical, Inc.
Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
Open, Classified
OJKNone listed
Jun 29, 2026Medline Industries, LP
Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A
Open, Classified
OJKNone listed
Jun 17, 2026Medline Industries, LP
MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775I; 2) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS983775J; 3) RETINA LAC/USC CDS, Medline Kit Nu
Open, Classified
OJKNone listed
Jun 12, 2026Medline Industries, LP
Medline convenience kits: BASIC EYE DYNJ905154I TUBAL LIGATION CDS CDS760053K
Open, Classified
OJKNone listed
May 28, 2026Medline Industries, LP
Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P
Open, Classified
OJKNone listed
May 7, 2026Medline Industries, LP
Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DY
Open, Classified
OJKNone listed
Apr 30, 2026Medline Industries, LP
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A; 2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B; 3. OCUL
Open, Classified
OJKNone listed
Apr 17, 2026Medline Industries, LP
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A
Open, Classified
OJKNone listed
Apr 7, 2026Medline Industries, LP
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: TAVR PACK, Medline SKU # DYNJ84472
Open, Classified
OJKNone listed
Feb 17, 2026Medline Industries, LP
Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DY
Open, Classified
OJKNone listed
Nov 14, 2025Medline Industries, LP
MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #81, REF DYNJ27466T.
Open, Classified
OJKNone listed
Nov 14, 2025Medline Industries, LP
MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.
Open, Classified
OJKNone listed
Oct 16, 2025American Contract Systems Inc.
Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 PERP25AQ PEI RETINAL PACK-206025 RFEY
Open, Classified
OJKNone listed
Jun 30, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
Open, Classified
OJKNone listed
May 1, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
Open, Classified
OJKNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model Number: DYNJ60631B; 3) CATARACT PACK, Model Number: DYNJ80316A; 4) BASIC EYE PACK
Open, Classified
OJKNone listed
Mar 25, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V; 2) CATARACT CM-LF, Pack Number DYNJ39921B; 3) CATARACT EYE, Pack Number DYNJ45662C; 4) CATARACT PACK, Pack N
Open, Classified
OJKNone listed
Mar 18, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC
Open, Classified
OJKNone listed
Feb 10, 2025Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Nu
Open, Classified
OJKNone listed
Jan 15, 2025Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH1; 3) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH2; 4) KIT,H N FR
Open, Classified
OJKNone listed
Dec 5, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYNJ43147G; 4) OSC OCULOPLASTIC PACK, REF DYNJ63329D; 5) OSC OCULOP
Open, Classified
OJKNone listed
Nov 19, 2024Alcon Research LLC
a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-
Open, Classified
OJKNone listed
Oct 23, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
Open, Classified
OJKNone listed
Oct 23, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK, REF DYNJ24573K; 4) EYE PACK, REF DYNJ30327A; 5) BASIC CATAR
Open, Classified
OJKNone listed
Sep 11, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B; b) AMB VITRECTOMY, Pack Number DYNJ59921BH; c) AMB OCULOPLASTICS MUSC,
Open, Classified
OJKNone listed
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number CDS760053K ; 3) CATARACT CDS, Pack Number CDS810010J ; 4) CATARACT CDS, Pack Nu
Open, Classified
OJKNone listed
Aug 28, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC CATARACT PACK , Pack Number DYNJ0855117O ; 3) BAI , Pack Number DYNJ53847D ; 4) BASIC EYE PACK, Pack Numbe
Open, Classified
OJKNone listed
Aug 7, 2024American Contract Systems, Inc.
American Contract Systems Cataract Pack convenience kit
Open, Classified
OJKNone listed
Feb 25, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ68875F; c) CATARACT PACK, REF DYNJ54869F; d) CATARACT PREP PACK, REF DYNJ44917L; e
Open, Classified
OJKNone listed
Jan 26, 2024American Contract Systems, Inc.
Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Laminectomy, kit number UIOL34AG
Open, Classified
OJKNone listed
Aug 3, 2023MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB PACK, Model Number: DYNJ58351A; b. PV CAROTID PACK, Model Number: DYNJ633
Open, Classified
OJKNone listed
Jul 20, 2023MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: CATH LAB PACK, Model Number DYNJ58351A
Open, Classified
OJKNone listed
Feb 6, 2023MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PACK-LF e. EYE PACK f. OCULOPLASTIC PACK g. EYE PLASTIC PACK
Open, Classified
OJKNone listed
Nov 23, 2022ROi CPS LLC
regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit
Terminated
OJKNone listed
Nov 23, 2022ROi CPS LLC
regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit
Terminated
OJKNone listed
Nov 23, 2022ROi CPS LLC
regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit
Terminated
OJKNone listed
Nov 23, 2022ROi CPS LLC
regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit
Terminated
OJKNone listed
Nov 23, 2022ROi CPS LLC
regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit
Terminated
OJKNone listed
Nov 23, 2022ROi CPS LLC
regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit
Terminated
OJKNone listed
Nov 1, 2022MEDLINE INDUSTRIES, LP - Northfield
BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures.
Open, Classified
OJKNone listed
Nov 1, 2022MEDLINE INDUSTRIES, LP - Northfield
BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures.
Open, Classified
OJKNone listed
Nov 1, 2022MEDLINE INDUSTRIES, LP - Northfield
BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgical procedures.
Open, Classified
OJKNone listed
Nov 1, 2022MEDLINE INDUSTRIES, LP - Northfield
BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures.
Open, Classified
OJKNone listed
Nov 1, 2022MEDLINE INDUSTRIES, LP - Northfield
BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures.
Open, Classified
OJKNone listed
Jun 16, 2022American Contract Systems, Inc.
Various eye packs, cataract packs
Open, Classified
OJKNone listed

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