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 8, 2021 | Beaver Visitec International, Inc. bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for evaluation purposes
REF# BVI 58000587 Open, Classified |
OJK | None listed |
| Oct 8, 2021 | Beaver Visitec International, Inc. bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component
REF# 58000572
REF#: 373809 Open, Classified |
OJK | None listed |
| Oct 8, 2021 | Beaver Visitec International, Inc. bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component
a) REF# 588221
REF#: 373809 Open, Classified |
OJK | None listed |
| Aug 10, 2021 | ROi CPS LLC REGARD Vitrectomy Tray Terminated |
OJK | None listed |
| Aug 10, 2021 | ROi CPS LLC REGARD Basic Cataract tray Terminated |
OJK | None listed |
| Feb 18, 2020 | Avid Medical, Inc. Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers. Terminated |
OJK | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 900944
CATARACT SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OJK | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9001933
OPHTALMIC SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OJK | None listed |
| Apr 14, 2016 | Customed, Inc Catalog Number: 9001780
OPHTHALMIC SURGICAL PACK
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OJK | None listed |
| Sep 3, 2015 | Customed, Inc CATARACT PACK 6/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate Terminated |
OJK | None listed |
| Sep 3, 2015 | Customed, Inc OPHTHALMIC PACK 6/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OJK | None listed |
| Sep 3, 2015 | Customed, Inc OPHTHALMIC PACK 6/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OJK | None listed |
| Sep 3, 2015 | Customed, Inc RETINA PACK 7/CS
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
. Terminated |
OJK | None listed |
| Dec 16, 2014 | Customed, Inc Cataract Pack, Catalog # 900-944
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OJK | None listed |
| Dec 16, 2014 | Customed, Inc Ophtalmic Pack, Catalog number 900-1933.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OJK | None listed |
| Dec 16, 2014 | Customed, Inc Ophtalmic Pack, Catalog number 900-1780.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OJK | None listed |
| Dec 16, 2014 | Customed, Inc Retina Pack, Catalog number 900-1611.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
OJK | None listed |
| Aug 29, 2014 | Customed, Inc MINOR PACK
CONTENTS:
(1) TOWELS ABSORBENT 15" X 20"
(1) WRAPPER 24" X 24" (16) GAUZE SPONGES 2" X 2" 8PLY (1) TRAY HALF SHALLOW
(12) COTION TIP APPLICATOR 6" WOOD
(2) GLOVE SKY NITRILE Terminated |
OJK | None listed |
| Aug 29, 2014 | Customed, Inc OPHTALMIC PACK-
(1) TABLE COVER REINF. 44" X 78" UF
(1) GOWN SMS XLGE STD UF
(2) TOWEL ABSORBENT 15" X 20" LIF
(1) SYRINGE 3cc W/0 NDL LILOCK UF
(1) MAYO STAND COVER REINF. LIF
(1) NEEDLE HYPODERM Terminated |
OJK | None listed |
| Aug 29, 2014 | Customed, Inc OPHTALMIC PACK -
(1) GOWN LGE SMS NON REINF TIWRAP
(1) IODINE POVIDONE 1oz.
(2) TOWEL ABSORBENT 15" x 20" UF
(1) SYRINGE 3cc W/NEEDLE 21 G X 1 Y. UF
(6) COTION TIP APPLICATOR 6" WOOD
(1) TABLE C Terminated |
OJK | None listed |
| Aug 29, 2014 | Customed, Inc RETINA PACK -
(1) TABLE COVER REINFORCED 44" X 78" LIF
(50) COTTON TIP APPLICATOR 6" WOOD LIF
(2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE
(2) MEDECINE CUP 2oz LIF
(5) TOWELS ABSORBENT 15" X 20" LIF
( Terminated |
OJK | None listed |
| Aug 29, 2014 | Customed, Inc PREMIUM OPHTHALMIC PACK- CUSTOMED-
(1) GOWN SMS X-LARGE STD RAGLAN
(1) CUP MEDICINE 2oz
(1) DRAPE OPHTHAL. WITH POUCH LIF
(1 0) SPONGE EYE SPEAR MICRO
(1) SHIELD EYE UNIVERSAL
(6) COTTON TIP APPLICAT Terminated |
OJK | None listed |
| Aug 29, 2014 | Customed, Inc CATARACT PACK- OJOS INC.-
(1) TABLE COVER REINF. 44" X 78" L/F
(2) MEDICINE CUP 1oz.
(2) ABSORBENT TOWEL 15" X 20" LIF
(1 0) EYE SPEAR MICRO SPONGE
(1) EYE PAD 2 1/8 X 2 5/8 LIF
(4) DRAPE UTILITY Terminated |
OJK | None listed |
| Aug 29, 2014 | Customed, Inc OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF
(1) MAYO STAND COVER REINFORCED LIF
(1) OPHTALMIC DRAPE WITH POUCH LIF
(2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF
(10) COTTON TIP APPLICATOR 6" WO Terminated |
OJK | None listed |
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