Data / Medical devices / Canada / Pronorth Medical
Pronorth Medical: FDA-registered device maker in ABBOTSFORD British Columbia, Canada, 33 510(k) clearances and 1 PMA approval
Pronorth Medical is registered with the FDA (registration 3029901632) in ABBOTSFORD British Columbia, Canada. It lists 24 device types. The FDA files 33 510(k) clearances and 1 PMA approval under its listings, the newest dated January 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029901632
- Address
- 6-2290 Boley ST., ABBOTSFORD British Columbia, Canada, V3G0J1
- Owner or operator
- ProNorth Medical (10087056)
- Roles
- Exporter to the US
- First device listed
- October 23, 2023
- Registered through
- 2026
- Brand names listed
- Blood collection tubes, Caprosyn, Conduction Needle, DemeCaprone, Demelene, Dental Intruments, Electrode, Hypodermic Needle and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 12, 2024 | K233022 | Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small | MSH | Substantially Equivalent | Owens & Minor (O&M) Halyard, Inc. | accessdata.fda.gov |
| August 11, 2023 | K231408 | Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile | LZA | Substantially Equivalent | Shandong Intco Medical Products Co, Ltd. | accessdata.fda.gov |
| December 22, 2021 | K210978 | BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle | BSP | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| December 21, 2020 | K201996 | Monocryl Plus Antibacterial Suture | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| September 28, 2018 | K181652 | Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| July 13, 2016 | K160744 | LOOK PTFE Suture | NBY | Substantially Equivalent | Surgical Specialties Corporation | accessdata.fda.gov |
| July 18, 2014 | K141625 | POLYSYN SURGICAL SUTURE | GAM | Substantially Equivalent | Surgical Specialties Corp | accessdata.fda.gov |
| July 11, 2014 | K141558 | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE | GAM | Substantially Equivalent | Surgical Specialties Corp | accessdata.fda.gov |
| March 26, 2014 | K140415 | MONOTEX | NBY | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| December 6, 2013 | K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | GAW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| July 17, 2013 | K130083 | DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE | GAM | Substantially Equivalent | Demetech Corp. | accessdata.fda.gov |
| May 16, 2013 | K131224 | SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE | GAW | Substantially Equivalent | Surgical Specialties Corp. Dba Angiotech | accessdata.fda.gov |
| November 12, 2009 | K093408 | V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE | GAM | Substantially Equivalent | Surgical Devices, A Division of Tyco Healthcare | accessdata.fda.gov |
| September 21, 2009 | K091942 | POWDER-FREE, VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Zibo Intco Medical Products Co., Ltd. | accessdata.fda.gov |
| July 14, 2006 | K061037 | PDS PLUS ANTIBACTERIAL SUTURE | NEW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| November 7, 2005 | K052437 | MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE | GAM | Substantially Equivalent | Surgical Specialties Corp | accessdata.fda.gov |
| May 16, 2005 | K043330 | POLYPROPILENE SURGICAL SUTURES | GAW | Substantially Equivalent | Demetech Corp. | accessdata.fda.gov |
| December 18, 2003 | K033746 | MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| November 17, 2003 | K032586 | CAPROSYN ABSORBABLE SUTURE | GAM | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| September 13, 2002 | K022269 | COATED VICRYL* (POLYGLACTIN 910) SUTURE | GAM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| April 1, 1999 | K990951 | MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE | GAM | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| October 28, 1998 | K982541 | VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 | FMI | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| April 9, 1997 | K970796 | 3M RED DOT 2560 & 2570 MONITORING ELECTRODES | DRX | Substantially Equivalent | 3M Healthcare | accessdata.fda.gov |
| February 10, 1997 | K965202 | VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET | JKA | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| December 18, 1996 | K964072 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED | GAN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| March 28, 1996 | K960653 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) | GAN | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| November 28, 1995 | K954592 | VACUTAINER BRAND PST PLASMA SEPARATION TUBE | JKA | Substantially Equivalent | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| January 9, 1995 | K946173 | STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK | GAQ | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| September 9, 1992 | K923689 | SURGISTAR BLADES | GDX | Substantially Equivalent | Surgistar, Inc. | accessdata.fda.gov |
| January 31, 1991 | K904972 | SURGICARE STERILE SURGICAL GLOVES | KGO | Substantially Equivalent | Kanam Latex Industries Pvt. , Ltd. | accessdata.fda.gov |
| October 25, 1990 | K903029 | STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE | GAR | Substantially Equivalent | Look, Inc. | accessdata.fda.gov |
| May 31, 1990 | K896554 | GUT SUTURES | GAL | Substantially Equivalent for Some Indications | Look, Inc. | accessdata.fda.gov |
| June 6, 1986 | K861947 | SURGICAL KNIFE | EMF | Substantially Equivalent | Sharpoint, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 14, 1960 | N12159 | SURGICEL BRAND ABSORBABLE HEMOSTAT | LMG | 120 | July 28, 2026 | accessdata.fda.gov |
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Updated July 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.