Data / Medical devices / United States / Argon Medical Devices, Inc.
Argon Medical Devices, Inc.: FDA-registered device maker in Wheeling, IL, United States, 26 510(k) clearances
Argon Medical Devices, Inc. is registered with the FDA (registration 1417485) in Wheeling, IL, United States. It lists 34 device types. The FDA files 26 510(k) clearances under its listings, the newest dated November 1, 2005. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1417485
- Address
- 241 W Palatine Rd, Wheeling, IL, United States, 60090
- Owner or operator
- ARGON MEDICAL DEVICES, INC (9059795)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- April 18, 2013
- Registered through
- 2026
- Brand names listed
- 11 guage Bone Access Needles, 16GA High Flow Needle, ACN, SACN, Biopsy Needle, Abrivo Introducer, Access Needle, Access needles, Accura Breast Localization Needles, Accura II Breast Localization Needles (Sadowsky Style) 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 |
|---|---|---|---|---|---|---|
| November 1, 2005 | K052802 | MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE | KNW | Substantially Equivalent | Manan Medical Products, Inc. | accessdata.fda.gov |
| January 8, 1999 | K983620 | MANAN SPINAL NEEDLES | BSP | Substantially Equivalent | Manan Medical Products, Inc. | accessdata.fda.gov |
| July 31, 1998 | K980536 | EPIDURAL NEEDLE | BSP | Substantially Equivalent | Manan Medical Products, Inc. | accessdata.fda.gov |
| June 29, 1998 | K981386 | MANAN BLUNT NEEDLE | FPA | Substantially Equivalent | Manan Medical Products, Inc. | accessdata.fda.gov |
| January 30, 1998 | K980122 | MANAN SOFT TISSUE BIOPSY NEEDLES | KNW | Substantially Equivalent | Medical Device Technologies, Inc. | accessdata.fda.gov |
| January 8, 1998 | K974446 | MANAN AUTOMATIC CUTTING NEEDLE | KNW | Substantially Equivalent | Manan Medical Products, Inc. | accessdata.fda.gov |
| January 10, 1997 | K962001 | MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE | FMI | Substantially Equivalent | Manan Medical Products, Inc. | accessdata.fda.gov |
| May 23, 1996 | K961216 | MANAN INTRODUCER SHEALTH/NEEDLE | FGE | Substantially Equivalent | Manan Medical Products, Inc. | accessdata.fda.gov |
| March 2, 1995 | K950732 | MANAN SUPER-CORE BIOPSY NEEDLE | KNW | Substantially Equivalent | Manan Medical Products, Inc. | accessdata.fda.gov |
| September 29, 1994 | K943651 | TECHNA-CUT ASPIRATION NEEDLE | KNW | Substantially Equivalent | Manan Medical Products, Inc. | accessdata.fda.gov |
| February 25, 1994 | K940025 | MANAN BONE MARROW HARVEST NEEDLES | GAA | Substantially Equivalent | Manan Medical Products, Inc. | accessdata.fda.gov |
| February 25, 1994 | K940024 | MANAN GENERAL PURPOSE INTRODUCER NEEDLE | GAA | Substantially Equivalent | Manan Medical Products, Inc. | accessdata.fda.gov |
| August 10, 1990 | K902622 | MANAN PROSTATE SEEDING NEEDLE | KXK | Substantially Equivalent | Manan Medical Products, Inc. | accessdata.fda.gov |
| April 11, 1989 | K890925 | MANAN BONE MARROW BIOPSY NEEDLE | DWO | Substantially Equivalent | Manan Medical Products, Inc. | accessdata.fda.gov |
| September 28, 1988 | K883744 | MANAN HUBER STYLE INFUSION NEEDLE | FMF | Substantially Equivalent | Manan Medical Products, Inc. | accessdata.fda.gov |
| October 14, 1986 | K863848 | MANAN BREST TUMOR LOCALIZATION NEEDLE | GAA | Substantially Equivalent | Manan Manufacturing Co., Inc. | accessdata.fda.gov |
| July 11, 1985 | K851834 | MANAN GWI GUIDE WIRE INTRODUCER | DWS | Substantially Equivalent | Manan Manufacturing Co., Inc. | accessdata.fda.gov |
| July 11, 1985 | K851833 | MANAN SELDINGER NEEDLE | DWS | Substantially Equivalent | Manan Manufacturing Co., Inc. | accessdata.fda.gov |
| July 11, 1985 | K851832 | NAMAN POTTS COURNAND NEEDLE | DWS | Substantially Equivalent | Manan Manufacturing Co., Inc. | accessdata.fda.gov |
| June 27, 1985 | K852428 | MANAN EPIDURAL NEEDLE | GCB | Substantially Equivalent | Manan Manufacturing Co., Inc. | accessdata.fda.gov |
| June 27, 1985 | K852427 | MANAN SPINAL NEEDLE | GAA | Substantially Equivalent | Manan Manufacturing Co., Inc. | accessdata.fda.gov |
| June 27, 1985 | K852426 | MANAN TROCAR STYLE BIOPSY NEEDLE | GAA | Substantially Equivalent | Manan Manufacturing Co., Inc. | accessdata.fda.gov |
| June 21, 1985 | K851838 | MANAN CHIBA PTC NEEDLE | KNW | Substantially Equivalent | Manan Manufacturing Co., Inc. | accessdata.fda.gov |
| May 17, 1985 | K851835 | MANAN GREENE NEEDLE | KNW | Substantially Equivalent | Manan Manufacturing Co., Inc. | accessdata.fda.gov |
| May 14, 1985 | K851837 | MANAN WESTCOTT NEEDLE | KNW | Substantially Equivalent | Manan Manufacturing Co., Inc. | accessdata.fda.gov |
| May 14, 1985 | K851831 | MANAN FRANSEENE NEEDLE | KNW | Substantially Equivalent | Manan Manufacturing Co., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 18, 2018 | 81968 | Class II | Terminated | "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration. | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line | accessdata.fda.gov |
| May 3, 2005 | 31963 | Not yet classified | Terminated | Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a white molded plastic hub. The non-sterile prostate seeding needles were shipped in bulk for packaging, sterilization and dis | The hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures. | accessdata.fda.gov |
Compare with other makers
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Updated November 1, 2005. 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.