FDA Device Registration & Listing · Vaughan Ontario, CA · Registration 3011689956
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 |
|---|---|---|---|---|---|
| HIB | Speculum, Vaginal, Nonmetal | Obstetrics/Gynecology | Class 2 | 884.4530 | 2025-05-07 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | General, Plastic Surgery | Class 2 | 878.4495 | 2020-01-01 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2020-01-01 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | General, Plastic Surgery | Class 2 | 878.5020 | 2020-01-01 |
| GAL | Suture, Absorbable, Natural | General, Plastic Surgery | Class 2 | 878.4830 | 2020-01-01 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | Class 2 | 878.5010 | 2020-01-01 |
| GAP | Suture, Nonabsorbable, Silk | General, Plastic Surgery | Class 2 | 878.5030 | 2020-01-01 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2020-01-01 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2025-05-07 |
| FTL | Mesh, Surgical, Polymeric | General, Plastic Surgery | Class 2 | 878.3300 | 2025-08-25 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2021-06-14 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2025-04-25 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2021-11-18 |
| IQK | Orthosis, Cervical | Physical Medicine | Class 1 | 890.3490 | 2017-02-28 |
| MEG | Syringe, Antistick | General Hospital | Class 2 | 880.5860 | 2025-05-27 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | General, Plastic Surgery | Class 2 | 878.4840 | 2025-05-21 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2025-05-21 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2025-06-03 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2022-04-13 |
| MVL | Cord, Retraction | Unknown | Class U | N/A | 2019-01-07 |
| ITG | Bandage, Cast | Physical Medicine | Class 1 | 890.3025 | 2017-05-16 |
| FZZ | Marker, Skin | General, Plastic Surgery | Class 1 | 878.4660 | 2025-05-07 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2017-09-08 |
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | Ophthalmic | Class 1 | 886.1860 | 2025-06-03 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2025-05-22 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2022-11-18 |
| JOH | Tube Tracheostomy And Tube Cuff | Anesthesiology | Class 2 | 868.5800 | 2019-05-15 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2017-06-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2018-10-23 |
| CAE | Airway, Oropharyngeal, Anesthesiology | Anesthesiology | Class 1 | 868.5110 | 2022-12-07 |
| SDV | Clinical Electronic Thermometer | General Hospital | Class 2 | 880.2910 | 2026-06-17 |
| EXG | Bag, Urine Collecting, Ureterostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2017-04-26 |
| GAN | Suture, Absorbable, Synthetic | General, Plastic Surgery | Class 2 | 878.4830 | 2025-05-21 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2025-06-24 |
| ELZ | Crown, Preformed | Dental | Class 1 | 872.3330 | 2017-04-18 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | General, Plastic Surgery | Class 1 | 878.4450 | 2024-01-17 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | Class 1 | 872.6030 | 2019-03-05 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2017-09-08 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2025-06-24 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2025-05-21 |
| GAN | Suture, Absorbable, Synthetic | General, Plastic Surgery | Class 2 | 878.4830 | 2025-05-21 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2017-02-23 |
| HDQ | Dilator, Cervical, Fixed Size | Obstetrics/Gynecology | Class 1 | 884.4530 | 2024-02-27 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2017-04-10 |
| EZR | Cement, Stomal Appliance, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2017-02-28 |
| FMH | Container, Specimen, Sterile | Pathology | Class 1 | 864.3250 | 2025-06-13 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2021-06-14 |
| GWM | Device, Monitoring, Intracranial Pressure | Neurology | Class 2 | 882.1620 | 2017-03-15 |
| HIB | Speculum, Vaginal, Nonmetal | Obstetrics/Gynecology | Class 2 | 884.4530 | 2025-05-27 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2017-02-22 |
| MMK | Container, Sharps | General Hospital | Class 2 | 880.5570 | 2026-03-03 |
| EHJ | Disk, Abrasive | Dental | Class 1 | 872.6010 | 2017-04-18 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | Neurology | Class 2 | 882.4300 | 2017-06-27 |
| LJX | Test, Urine Leukocyte | Hematology | Class 1 | 864.7675 | 2017-10-16 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2025-05-07 |
| BWF | Spirometer, Therapeutic (Incentive) | Anesthesiology | Class 2 | 868.5690 | 2024-09-25 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2017-06-27 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2019-01-14 |
| EMB | Zinc Oxide Eugenol | Dental | Class 1 | 872.3275 | 2018-10-09 |
| FTL | Mesh, Surgical, Polymeric | General, Plastic Surgery | Class 2 | 878.3300 | 2026-03-03 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2025-05-07 |
| IQI | Orthosis, Limb Brace | Physical Medicine | Class 1 | 890.3475 | 2017-05-05 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2018-12-27 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2025-06-02 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2025-06-02 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2021-06-14 |
| JSM | Culture Media, Non-Propagating Transport | Microbiology | Class 1 | 866.2390 | 2025-06-13 |
| LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery | Class 3 | 878.4490 | 2024-02-13 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2019-03-28 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2019-03-28 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2019-03-28 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2018-10-09 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2025-05-08 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2021-11-22 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2025-06-02 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | Neurology | Class 2 | 882.4460 | 2017-06-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2025-05-12 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2023-07-06 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2025-05-08 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | Class 2 | 880.5200 | 2025-05-14 |
| EXB | Collector, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2019-09-06 |
| ERA | Otoscope | Ear, Nose, Throat | Class 1 | 874.4770 | 2021-12-08 |
| JIO | Blood, Occult, Colorimetric, In Urine | Hematology | Class 2 | 864.6550 | 2025-06-03 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | Clinical Chemistry | Class 2 | 862.1340 | 2025-06-03 |
| JFY | Enzymatic Method, Creatinine | Clinical Chemistry | Class 2 | 862.1225 | 2025-06-03 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | Clinical Chemistry | Class 1 | 862.1435 | 2025-06-03 |
| JJB | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | Clinical Chemistry | Class 1 | 862.1115 | 2025-06-03 |
| JRE | Refractometer For Clinical Use | Clinical Chemistry | Class 1 | 862.2800 | 2025-06-03 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | Clinical Chemistry | Class 1 | 862.1550 | 2025-06-03 |
| LJX | Test, Urine Leukocyte | Hematology | Class 1 | 864.7675 | 2025-06-03 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Clinical Chemistry | Class 1 | 862.1645 | 2025-06-03 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Clinical Chemistry | Class 1 | 862.1510 | 2025-06-03 |
| CDM | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | Clinical Chemistry | Class 1 | 862.1785 | 2025-06-03 |
| IPT | Orthosis, Thoracic | Physical Medicine | Class 1 | 890.3490 | 2017-02-28 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2025-05-07 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2018-10-23 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2017-07-24 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | Class 2 | 878.5010 | 2025-05-21 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2025-05-07 |
| KGO | Surgeon'S Gloves | General, Plastic Surgery | Class 1 | 878.4460 | 2025-05-07 |
| IQE | Orthosis, Lumbar | Physical Medicine | Class 1 | 890.3490 | 2021-04-09 |
| JOW | Sleeve, Limb, Compressible | Cardiovascular | Class 2 | 870.5800 | 2025-08-14 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2025-05-21 |
| JTW | System, Transport, Aerobic | Microbiology | Class 1 | 866.2900 | 2025-05-07 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2025-05-27 |
| EXE | Protector, Ostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2017-02-28 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-05-12 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K072322 | Smith & Nephew, Inc. | ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS | 2007-09-18 |
| K241486 | Covidien | Sofsilk Coated Braided Silk Suture | 2024-12-03 |
| K123940 | Demetech Corp. | DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE | 2014-05-30 |
| K050845 | ETHICON, Inc. | MONOCRYL PLUS ANTIBACTERIAL SUTURE | 2005-06-29 |
| K945777 | Smiths Industries Medical Systems, Inc. | PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES | 1994-12-22 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0034-2009 | Surgical Specialties Corp | 2 | 3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures. |
| Z-0010-2021 | Riverpoint Medical, LLC | 2 | Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. |
| Z-0011-2021 | Riverpoint Medical, LLC | 2 | Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. |
| Z-0012-2021 | Riverpoint Medical, LLC | 2 | Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. |
| Z-0013-2021 | Riverpoint Medical, LLC | 2 | Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3016250458 | ILLUMIGYN LTD. | Neve Ilan Central, IL |
| 3016884191 | JIANGSU RONGYE TECHNOLOGY CO.,LTD | Yangzhou Jiangsu, CN |
| 1216677 | COOPERSURGICAL, INC. | Trumbull, CT, US |
| 3037918935 | Pharmamed SA. | Anderlecht Brussels-Capital Region, BE |
| 3009308092 | SUZHOU PIPI MEDICAL PRODUCTS CO.,LTD | Suzhou Jiangsu, CN |
3011689956 when referencing this establishment in official correspondence.