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)
Top companies in OJK
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D Open, Classified |
OJK | None listed |
| Sep 16, 2026 | Medline Industries, LP Convenience kits
CATARACT PACK
DYNJ59881A Open, Classified |
OJK | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
CATARACT PREOP KIT
DYKS1583A Open, Classified |
OJK | None listed |
| Aug 31, 2026 | Medline 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 |
OJK | None listed |
| Aug 13, 2026 | Cardinal 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 |
OJK | None listed |
| Jul 20, 2026 | AVID Medical, Inc. Halyard EYE PACK. Model/Catalog Number: LVEY27
Convenience kit. Open, Classified |
OJK | None listed |
| Jun 29, 2026 | Medline Industries, LP Medline Convenience Kits:
1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A Open, Classified |
OJK | None listed |
| Jun 17, 2026 | Medline 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 |
OJK | None listed |
| Jun 12, 2026 | Medline Industries, LP Medline convenience kits:
BASIC EYE
DYNJ905154I
TUBAL LIGATION CDS
CDS760053K Open, Classified |
OJK | None listed |
| May 28, 2026 | Medline Industries, LP Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P Open, Classified |
OJK | None listed |
| May 7, 2026 | Medline 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 |
OJK | None listed |
| Apr 30, 2026 | Medline 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 |
OJK | None listed |
| Apr 17, 2026 | Medline Industries, LP Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes
EYE PACK DYNJ35056A
HEART CATH PACK DYNJ69318A Open, Classified |
OJK | None listed |
| Apr 7, 2026 | Medline 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 |
OJK | None listed |
| Feb 17, 2026 | Medline 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 |
OJK | None listed |
| Nov 14, 2025 | Medline Industries, LP MEDLINE convenience kits labeled as:
1) MINOR EYE TRAY #81, REF DYNJ27466S;
2) MINOR EYE TRAY #81, REF DYNJ27466T. Open, Classified |
OJK | None listed |
| Nov 14, 2025 | Medline Industries, LP MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F. Open, Classified |
OJK | None listed |
| Oct 16, 2025 | American 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 |
OJK | None listed |
| Jun 30, 2025 | MEDLINE 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 |
OJK | None listed |
| May 1, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K Open, Classified |
OJK | None listed |
| Apr 17, 2025 | MEDLINE 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 |
OJK | None listed |
| Mar 25, 2025 | MEDLINE 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 |
OJK | None listed |
| Mar 18, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) EYE PACK, Pack Number VAL038BSCLC Open, Classified |
OJK | None listed |
| Feb 10, 2025 | Cardinal 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 |
OJK | None listed |
| Jan 15, 2025 | Cardinal 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 |
OJK | None listed |
| Dec 5, 2024 | MEDLINE 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 |
OJK | None listed |
| Nov 19, 2024 | Alcon 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 |
OJK | None listed |
| Oct 23, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit Open, Classified |
OJK | None listed |
| Oct 23, 2024 | MEDLINE 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 |
OJK | None listed |
| Sep 11, 2024 | MEDLINE 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 |
OJK | None listed |
| Sep 6, 2024 | MEDLINE 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 |
OJK | None listed |
| Aug 28, 2024 | MEDLINE 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 |
OJK | None listed |
| Aug 7, 2024 | American Contract Systems, Inc. American Contract Systems Cataract Pack convenience kit Open, Classified |
OJK | None listed |
| Feb 25, 2024 | MEDLINE 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 |
OJK | None listed |
| Jan 26, 2024 | American 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 |
OJK | None listed |
| Aug 3, 2023 | MEDLINE 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 |
OJK | None listed |
| Jul 20, 2023 | MEDLINE INDUSTRIES, LP - Northfield Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:
CATH LAB PACK, Model Number DYNJ58351A Open, Classified |
OJK | None listed |
| Feb 6, 2023 | MEDLINE 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 |
OJK | None listed |
| Nov 23, 2022 | ROi CPS LLC regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit Terminated |
OJK | None listed |
| Nov 23, 2022 | ROi CPS LLC regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit Terminated |
OJK | None listed |
| Nov 23, 2022 | ROi CPS LLC regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit Terminated |
OJK | None listed |
| Nov 23, 2022 | ROi CPS LLC regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit Terminated |
OJK | None listed |
| Nov 23, 2022 | ROi CPS LLC regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit Terminated |
OJK | None listed |
| Nov 23, 2022 | ROi CPS LLC regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit Terminated |
OJK | None listed |
| Nov 1, 2022 | MEDLINE INDUSTRIES, LP - Northfield BAUSCH + LOMB CATARACT PACK, REF VAL001CPMEA. Convenience kit used in surgical procedures. Open, Classified |
OJK | None listed |
| Nov 1, 2022 | MEDLINE INDUSTRIES, LP - Northfield BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures. Open, Classified |
OJK | None listed |
| Nov 1, 2022 | MEDLINE INDUSTRIES, LP - Northfield BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgical procedures. Open, Classified |
OJK | None listed |
| Nov 1, 2022 | MEDLINE INDUSTRIES, LP - Northfield BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures. Open, Classified |
OJK | None listed |
| Nov 1, 2022 | MEDLINE INDUSTRIES, LP - Northfield BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures. Open, Classified |
OJK | None listed |
| Jun 16, 2022 | American Contract Systems, Inc. Various eye packs, cataract packs Open, Classified |
OJK | None listed |
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