Data / Medical devices / Israel / T.A.G. Medical Products Corporation Ltd
T.A.G. Medical Products Corporation Ltd: FDA-registered device maker in GAATON Northern, Israel, 14 510(k) clearances
T.A.G. Medical Products Corporation Ltd is registered with the FDA (registration 8043971) in GAATON Northern, Israel. It lists 32 device types. The FDA files 14 510(k) clearances under its listings, the newest dated August 5, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8043971
- FEI number
- 1000272060
- Address
- Kibbutz Gaaton, GAATON Northern, Israel, 2513000
- Owner or operator
- TAG Medical products corporation LTD (9004870)
- Roles
- Manufacturer
- First device listed
- March 6, 1992
- Registered through
- 2026
- Brand names listed
- 1-72 UNF Tap, 1.1mm Guide Pin Trocar Tip, 1.28 Kit screwdriver, 1.8 Drill for 2.8 Anchor, 1/4" Abutment Fixture Long, 1/4" Abutment Fixture Short, 1/4" Holder & Collet Set, 10 X 30 mm Flexible Cannula 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 |
|---|---|---|---|---|---|---|
| August 5, 2026 | K253858 | GFS - Sterile Screws and Top Hat | HWC | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | accessdata.fda.gov |
| April 28, 2023 | K230058 | Bladeless Trocar Artemis Lap Cannula | GCJ | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | accessdata.fda.gov |
| September 7, 2022 | K221731 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | MBI | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | accessdata.fda.gov |
| March 24, 2021 | K210498 | Betta Link Knotless Implant System | MBI | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | accessdata.fda.gov |
| November 13, 2020 | K202178 | VersaLoop Anchor System | MBI | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | accessdata.fda.gov |
| May 19, 2019 | K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | MBI | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | accessdata.fda.gov |
| May 14, 2015 | K143326 | T.A.G. Dental Implant System | DZE | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | accessdata.fda.gov |
| October 16, 2014 | K142653 | G-Lok and G-Lok XL Extender | MBI | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | accessdata.fda.gov |
| March 2, 2012 | K113297 | KNOTILUS ANCHOR SYSTEM | MBI | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | accessdata.fda.gov |
| December 1, 2011 | K112296 | LATERAL BUTTON | MBI | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | accessdata.fda.gov |
| January 6, 2011 | K101616 | THE GRAPPLR AND GRAPPLR EXTENDER | MBI | Substantially Equivalent | Tag Medical Corp. | accessdata.fda.gov |
| August 9, 2010 | K100887 | VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY | KCT | Substantially Equivalent | Tag Medical Products | accessdata.fda.gov |
| July 7, 2009 | K091694 | MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM) | HWC | Substantially Equivalent | Tag Medical Products | accessdata.fda.gov |
| October 29, 2003 | K032119 | PARAGON MEDICAL SURGICAL INSTRUMENT DELIVERY SYSTEM VARIOUS | KCT | Substantially Equivalent | Paragon Medical, 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 |
|---|---|---|---|---|---|---|
| May 4, 2023 | 92410 | Class II | Ongoing | BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number:110045154 | Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury. | accessdata.fda.gov |
| January 20, 2020 | 85019 | Class II | Terminated | FlipCutter III Drill | There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier. | accessdata.fda.gov |
| December 4, 2009 | 54036 | Not yet classified | Terminated | Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair. Catalog Number: SMB000101 | Device failed to deploy the distal loop | accessdata.fda.gov |
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Updated August 5, 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.