FDA Device Registration & Listing · Brampton Ontario, CA · Registration 3016844398
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2024-03-25 |
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2026-06-12 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2026-05-13 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2026-03-30 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2026-06-12 |
| KNW | Instrument, Biopsy | Gastroenterology, Urology | Class 2 | 876.1075 | 2026-03-30 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2026-03-20 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-05-14 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2025-05-14 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2026-03-19 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | General Hospital | Class 1 | 880.6250 | 2026-03-19 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2026-03-19 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2026-03-19 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2025-05-14 |
| BTR | Tube, Tracheal (W/Wo Connector) | Anesthesiology | Class 2 | 868.5730 | 2026-03-02 |
| LYY | Latex Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2026-03-19 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2025-09-10 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2025-06-23 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2026-03-09 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2025-05-14 |
| LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery | Class 3 | 878.4490 | 2026-01-13 |
| FYC | Gown, Isolation, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2024-03-25 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2026-02-27 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2026-02-27 |
| CAK | Microfilter, Blood Transfusion | General Hospital | Class 2 | 880.5440 | 2026-04-23 |
| BSB | Warmer, Blood, Non-Electromagnetic Radiation | Hematology | Class 2 | 864.9205 | 2026-05-28 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2026-05-28 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2026-03-05 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2024-01-03 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2026-03-09 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2026-06-12 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2026-03-24 |
| LYZ | Vinyl Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2026-05-01 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2025-05-14 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2026-03-24 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2026-03-24 |
| FCG | Biopsy Needle | Gastroenterology, Urology | Class 2 | 876.1075 | 2026-03-30 |
| BTR | Tube, Tracheal (W/Wo Connector) | Anesthesiology | Class 2 | 868.5730 | 2026-04-28 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2025-05-14 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | General Hospital | Class 1 | 880.6250 | 2025-03-14 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-03-14 |
| QDO | Fentanyl And Other Opioid Protection Glove | General Hospital | Class 1 | 880.6250 | 2025-03-14 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2026-05-22 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2026-06-12 |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | General Hospital | Class 1 | 880.6250 | 2025-03-14 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2025-03-14 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2025-03-14 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2026-06-12 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2026-01-13 |
| DWJ | System, Thermal Regulating | Cardiovascular | Class 2 | 870.5900 | 2026-03-30 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K781371 | Ferris Mfg. Corp. | BONE MARROW ASPIRATION KIT | 1978-09-20 |
| K212801 | Hong Seng Gloves Sdn Bhd | Powder free nitrile examination glove- black, non sterile | 2022-01-09 |
| K260806 | Vista Industries,, LLC | Nitrile Disposable Examination Gloves | 2026-06-03 |
| K011593 | Ansell Healthcare Products, Inc. | MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE | 2001-06-21 |
| K981039 | Sri Johani Sdn. Bhd. | POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) | 1998-04-21 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0012-2008 | Becton Dickinson & Company | 1 | Shelf Pack:
Bard-Parker Rib-Back Carbon Steel no.11, surgical blade.
Unit Package:
Contents of unopened or undamaged package guaranteed sterile;
After use place product in a puncture resistant container and dispose properly.
Becton Dickinson
Becton Dickinson Acute Care
Franklin Lakes, NJ 07417 |
| Z-0013-2008 | Becton Dickinson & Company | 1 | Shelf Pack:
Bard-Parker Rib-Back Stainless Steel no.11, surgical blade.
Unit Package:
Contents of unopened or undamaged package guaranteed sterile;
After use place product in a puncture resistant container and dispose properly.
Becton Dickinson
Becton Dickinson Acute Care
Franklin Lakes, NJ 07417 |
| Z-0017-2023 | Hobbs Medical, Inc. | 1 | Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe
Catalog Number: 4620 |
| Z-0018-2023 | Hobbs Medical, Inc. | 1 | Hobbs Transbronchial Aspiration Needle
Catalog Number: 4621 |
| Z-0023-2011 | Becton Dickinson & Company | 1 | BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106.
Needles are intended for use in aspiration and injection of medications. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3040389290 | HUAIYIN MEDICAL INSTRUMENTS CO., LTD. | Huai an City Jiangsu, CN |
| 3014649053 | Sterilance Medical (Suzhou) Inc. | Suzhou Jiangsu, CN |
| 3013557562 | CBR ENTERPRISE LIMITED | Hong Kong, HK |
| 3009968482 | HU-FRIEDY MFG CO., LLC | Des Plaines, IL, US |
| 3004168759 | CENTRAL SURGICAL CO. PVT. LTD. | Sialkot Punjab, PK |
3016844398 when referencing this establishment in official correspondence.