FDA Device Registration & Listing · JUAREZ Chihuahua, MX · Registration 3005761322
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Unknown | Class U | N/A | 2021-01-14 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | Class 1 | 878.4014 | 2007-03-20 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2006-07-14 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-03-07 |
| ILH | Splint, Hand, And Components | Physical Medicine | Class 1 | 890.3475 | 2017-11-07 |
| FRL | Fiber, Medical, Absorbent | General Hospital | Class 1 | 880.5300 | 2016-12-29 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2012-12-26 |
| LRR | First Aid Kit With Drug | Unknown | Class N | N/A | 2013-01-30 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2012-12-26 |
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | Class 1 | 878.4018 | 2002-01-09 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2006-06-05 |
| MDA | Elastomer, Silicone, For Scar Management | General, Plastic Surgery | Class 1 | 878.4025 | 2006-06-05 |
| LWF | Dilator, Nasal | Ear, Nose, Throat | Class 1 | 874.3900 | 2006-06-05 |
| OHO | First Aid Kit Without Drug | General, Plastic Surgery | Class 1 | 878.4014 | 2017-07-28 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-05-03 |
| HMP | Pad, Eye | General, Plastic Surgery | Class 1 | 878.4440 | 1988-02-08 |
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | Class 1 | 890.5710 | 2008-02-02 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2023-11-16 |
| ILI | Sling, Arm | Physical Medicine | Class 1 | 890.3640 | 2017-06-12 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2007-03-20 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2023-10-24 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2017-02-13 |
No official correspondent registered.
| Registration Number | Establishment Name | Location |
|---|---|---|
| 9681195 | ASO PHILIPPINES, INC. | LAPU-LAPU CITY Cebu, PH |
| 3025145822 | ASO LLC | Palmetto, FL, US |
| 1038758 | ASO LLC | SARASOTA, FL, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K220566 | Koag, LLC | Vascette HP (hemostatic pad) | 2022-07-29 |
| K080818 | Hem Con Medical Technologies, Inc. | HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING | 2008-05-15 |
| K893123 | Les Laboratorires Brothier, S.A. | ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES | 1990-02-13 |
| K143462 | Benq Materials Corporation | AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) | 2015-05-08 |
| K040208 | Tz Medical, Inc. | NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND | 2004-05-11 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0003-06 | B. Braun Medical, Inc. | U | D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage. |
| Z-0038-2025 | 3M Company Health Care Business 3m Center | U | 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R |
| Z-0013-2019 | COVIDIEN LLC | 1 | Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332
Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing. |
| Z-0014-2019 | COVIDIEN LLC | 1 | Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715
Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds. |
| Z-0015-2019 | COVIDIEN LLC | 1 | Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880
Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3009348684 | Beeken Biomedical LLC | Newton, MA, US |
| 3004740112 | OVIK Health | Columbus, NC, US |
| 3006113097 | T-SCIENTIFIC INTERNATIONAL, INC. | SANTO DOMINGO Distrito Nacional, DO |
| 3005378067 | VEXXUS MEDICAL INC. | SANTO DOMINGO Distrito Nacional, DO |
| 1018233 | C.R. BARD, INC. | COVINGTON, GA, US |
3005761322 when referencing this establishment in official correspondence.