FDA Device Registration & Listing · Shawinigan Quebec, CA · Registration 3043051314
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2026-03-25 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2026-03-10 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2026-06-15 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2026-06-15 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2026-03-14 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | Class 1 | 880.6025 | 2026-03-14 |
| GXB | Esthesiometer | Neurology | Class 1 | 882.1500 | 2026-06-16 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2026-06-15 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2026-06-15 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | Class 1 | 878.4014 | 2026-03-08 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2026-01-27 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2026-03-08 |
| IKY | Mattress, Flotation Therapy, Non-Powered | General Hospital | Class 1 | 880.5150 | 2026-03-11 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2026-03-14 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2026-03-25 |
| MHW | Dressing, Compression | General Hospital | Class 1 | 880.5075 | 2026-06-16 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2025-12-26 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | Gastroenterology, Urology | Class 2 | 876.5250 | 2026-03-08 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2026-05-08 |
| OHY | Pill Crusher/Cutter | General Hospital | Class 1 | 880.6430 | 2026-03-08 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2026-05-08 |
| FZZ | Marker, Skin | General, Plastic Surgery | Class 1 | 878.4660 | 2026-06-19 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2026-03-08 |
| GAZ | Tubing, Noninvasive | General Hospital | Class 2 | 880.6740 | 2026-06-19 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2026-03-14 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K002933 | Maxxim Medical | STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES | 2000-10-19 |
| K913402 | Smith & Nephew Perry | PERRY(R) DERMAGUARD(R) PLUS GLOVES | 1991-10-02 |
| K221518 | Np Medical | NP Medical nCompass Extension Set with Stabilizing Base | 2022-11-03 |
| K953474 | Medikmark, Inc. | IV START KIT | 1995-10-02 |
| K972493 | Nipro Medical Corp. | NIPRO DISPOSABLE SOLUTION INFUSION SET | 1997-09-18 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0010-2025 | Smiths Medical ASD Inc. | 2 | CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24 |
| Z-0011-2025 | Smiths Medical ASD Inc. | 2 | CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24 |
| Z-0012-2013 | Baxter Healthcare Corp. Rt. | 2 | Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device.
Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device. |
| Z-0012-2025 | Smiths Medical ASD Inc. | 2 | CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24 |
| Z-0013-2013 | Baxter Healthcare Corp. Rt. | 2 | Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device;
Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 9610406 | ANSELL (THAILAND) LTD. | THAILAND Krung Thep Maha Nakhon, TH |
| 3012551999 | ST.MARYS RUBBERS PVT LTD | Kottayam Kerala, IN |
| 3025413681 | GUILIN HUADA BIOTECHNOLOGY CO., LTD. | Guilin City Guangxi, CN |
| 8041005 | WRP ASIA PACIFIC SDN. BHD. | SALAK TINGGI, SEPANG Selangor, MY |
| 3004122598 | PRODUCTOS MEDLINE S.A. DE C.V. | NUEVO LAREDO Tamaulipas, MX |
3043051314 when referencing this establishment in official correspondence.