Panels › General, Plastic Surgery › Product code OJU · Class 1
Skin Prep Tray
Regulation 878.4800
0510(k)s in 12 months (1 all time)
4recalls in 12 months (21 all time)
0recalls that name a 510(k)
Top companies in OJU
| Company | 510(k)s | Recalls |
|---|---|---|
| Medline Industries Inc | 0 | 6 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 6 |
| Centurion Medical Products Corporation | 0 | 3 |
| Carefusion 2200 Inc | 0 | 2 |
| American Contract Systems | 0 | 1 |
| American Optisurgical Inc | 0 | 1 |
| CareFusion 213, LLC | 0 | 1 |
| MEDLINE INDUSTRIES, LP - SPT | 0 | 1 |
| Pharmaseal Div., Baxter Healthcare Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
DELUXE PRE OP KIT
DYKS2018
GENERAL PREOP KIT
DYKS1584A
PRE OP KIT
DYKS1216I
PRE-OP KIT
DYKM1398B Open, Classified |
OJU | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) PRE-OP KIT, Catalog Number: DYKS1043F;
2) PRE OP KIT, Catalog Number: DYKS1128C;
3) PRE OP KIT, Catalog Number: DYKS1216I;
4) PRE OP KIT, Catalog Number: DYKS1325A;
5) Open, Classified |
OJU | None listed |
| Apr 30, 2026 | Medline Industries, LP Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395 Open, Classified |
OJU | None listed |
| Jan 12, 2026 | Medline Industries, LP Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as:
1) PRE OP KIT, Medline kit SKU DYKS1093B;
2) PRE OP KIT, Medline kit SKU DYKS1124C;
3) PRE OP KIT, Open, Classified |
OJU | None listed |
| Apr 17, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits used for various procedures:
1) SKIN LESION SET, Model Number: MNS6270 Open, Classified |
OJU | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) PREP TRAY, Pack Number DYNDA1540;
2) STERILE PREP TRAY , Pack Number DYNDA2499;
3) ED PREP TRAY, Pack Number DYNDA2519;
4) ED PREP TRAY, Pack Number DYNDA2 Open, Classified |
OJU | None listed |
| Aug 28, 2024 | MEDLINE INDUSTRIES, LP - Northfield Centurion procedure packs, containing Caina syringes, labeled as:
SHAVE KIT, Pack Number MNS8250 Open, Classified |
OJU | None listed |
| Mar 29, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724 Open, Classified |
OJU | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Kits, trays, and packs labeled as follows:
a) C L PREP, REF DYNJ69664;
b) DMEK PREP PACK, REF DYNJ81659A;
c) PRE OP KIT 1, REF DYKS1377;
d) PRE OP KIT 1, REF DYKS1377A Open, Classified |
OJU | None listed |
| Feb 10, 2023 | MEDLINE INDUSTRIES, LP - Northfield Surgical convenience kits labeled as:
MEDLINE PREP TRAY, Reorder Number DYNDL1643A Open, Classified |
OJU | None listed |
| Jun 6, 2022 | MEDLINE INDUSTRIES, LP - SPT Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG
Model/Catalog Number: Model numbers: a. DYNDP1127A, b. DYNDP1131 Open, Classified |
OJU | None listed |
| Apr 13, 2020 | American Contract Systems Sterile Custom Packs to be used in surgical procedures. Terminated |
OJU | None listed |
| Feb 10, 2020 | Medline Industries Inc Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration 06/30/2022. Terminated |
OJU | None listed |
| Feb 10, 2020 | Medline Industries Inc Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022. Terminated |
OJU | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-Skin Prep Trays
SP1180 DRY PREP SET
SP200 SKIN SCRUB TRAY
SP415 STERILE GAUZE SPONGE Terminated |
OJU | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion- Skin Prep Kits
SB1280 SKIN SCRUB KIT
SB1525 VAGINAL PREP TRAY Terminated |
OJU | None listed |
| Dec 11, 2019 | Centurion Medical Products Corporation Centurion-Skin Prep Tray
DYNDP1015 SKIN PREP TRAY Terminated |
OJU | None listed |
| Jun 6, 2013 | American Optisurgical Inc FAST Procedure Kit.
Intended for use as a Minor Surgical Procedures Tray. Terminated |
OJU | None listed |
| Mar 26, 2013 | CareFusion 213, LLC Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk.
Product Usage: Preoperative skin product Terminated |
OJU | None listed |
| Mar 14, 2012 | Carefusion 2200 Inc Wet PVP-I Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 4 oz. bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder Terminated |
OJU | None listed |
| Mar 14, 2012 | Carefusion 2200 Inc Wet PVP-I Small Procedure Preoperative Skin Prep Tray containing 1 - 59 mL bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 59 mL bottle Povidone Iodine Topical Solution (Paint) USP Terminated |
OJU | None listed |
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