Chrysalis Intelligence · Sponsors · T.A.G. Medical Products Corporation, Ltd.

T.A.G. Medical Products Corporation, Ltd.

Gaaton, IL · 6 510(k) clearances · 7 recalls

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Total clearances
6
2020-11-13 → 2026-08-05
Last 12 months
1
Product codes
3
Most recent
2026-08-05
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MBI Fastener, Fixation, Nondegradable, Soft Tissue Class II Orthopedic 3 2022-09-07
GCJ Laparoscope, General & Plastic Surgery Class II Gastroenterology, Urology 2 2023-08-04
HWC Screw, Fixation, Bone Class II Orthopedic 1 2026-08-05
Safety

Recalls (7)

Class I (serious)
0
Risk of injury / death
Total recalls
7
Currently ongoing
6
Most recent
2023-05-04
DateSeverityStatusRecall # ProductCodeReason
2023-05-04 Class II Ongoing Z-2065-2023 Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation in the repair of the natural lig… — 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…
2023-05-04 Class II Ongoing Z-2064-2023 Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation in the repair of the natural lig… — 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…
2023-05-04 Class II Ongoing Z-2063-2023 BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation in the repair of the natural lig… — 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…
2023-05-04 Class II Ongoing Z-2062-2023 BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation in the repair of the natural liga… — 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…
2023-05-04 Class II Ongoing Z-2061-2023 BETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligamen… — 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…
2023-05-04 Class II Ongoing Z-2060-2023 BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligamen… — 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…
2020-01-20 Class II Terminated Z-1542-2020 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.
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2026-08-05 K253858 GFS - Sterile Screws and Top Hat HWC Class II Orthopedic
2023-08-04 K231400 Bladeless Trocar – Artemis Lap Cannula GCJ Class II Gastroenterology, Urology
2023-04-28 K230058 Bladeless Trocar – Artemis Lap Cannula GCJ Class II Gastroenterology, Urology
2022-09-07 K221731 FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire MBI Class II Orthopedic
2021-03-24 K210498 Betta Link Knotless Implant System MBI Class II Orthopedic
2020-11-13 K202178 VersaLoop Anchor System MBI Class II Orthopedic
Data source: openFDA · Generated 2026-08-18 09:10 · Last ingest 2026-08-18T13:09:43.467718 · Pipeline: Chrysalis Intelligence