Panels › General, Plastic Surgery › Product code NAB · Class 1
Gauze / Sponge,Nonresorbable For External Use
Regulation 878.4014
0510(k)s in 12 months (88 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in NAB
| Company | 510(k)s | Recalls |
|---|---|---|
| Stan-Pak Ent. | 9 | 0 |
| Cal West Trading Co. | 8 | 0 |
| Hermitage Hospital Products, Inc. | 4 | 0 |
| Kerma Medical Products, Inc. | 4 | 0 |
| Kendall Research Center | 3 | 0 |
| North Health Care | 3 | 0 |
| Pac-Kit Safety Equipment Co. | 3 | 0 |
| Ulti-Med Intl., Inc. | 3 | 0 |
| Abco Dealers, Inc. | 2 | 0 |
| Hartmann USA, Inc | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2020 | Medline Industries Inc RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case; Sterile - Product Usage: are intended to absorb exudates. Terminated |
NAB | None listed |
| Dec 27, 2018 | Cardinal Health 200, LLC Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm)
Product Code: 8044 - Product Usage: Ideal for applying ointments, prepping, wiping needles, cleaning slides and more Rayon/p Terminated |
NAB | None listed |
| Oct 16, 2018 | ASO, LLC Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box Open, Classified |
NAB | None listed |
| Sep 11, 2015 | Revmedx Inc XGAUZE Trauma Dressing, catalog number FIN-0002-01.
XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, t Terminated |
NAB | None listed |
| Jun 22, 2012 | Hartmann USA, Inc Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges
For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing Terminated |
NAB | None listed |
| Jun 22, 2012 | Hartmann USA, Inc Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges
For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing Terminated |
NAB | None listed |
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