T.A.G. Medical Products Corporation Ltd
Bar-Lev Northern, IL
T.A.G. MEDICAL PRODUCTS CORPORATION LTD appears in FDA device records in Bar-Lev Northern, IL. FDA records list 17 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to T.A.G. Medical Products Corporation Ltd carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Tag Medical Corp.510(k), recall
510(k) clearance history
FDA records hold 17 510(k) clearances for T.A.G. Medical Products Corporation Ltd between 2002 and 2026. The busiest year on record is 2011, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 3 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253858 | GFS - Sterile Screws and Top Hat | HWC | Substantially Equivalent | |
| K231400 | Bladeless Trocar – Artemis Lap Cannula | GCJ | Substantially Equivalent | |
| K230058 | Bladeless Trocar – Artemis Lap Cannula | GCJ | Substantially Equivalent | |
| 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 | |
| K210498 | Betta Link Knotless Implant System | MBI | Substantially Equivalent | |
| K202178 | VersaLoop Anchor System | MBI | Substantially Equivalent | |
| 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 | |
| K143326 | T.A.G. Dental Implant System | DZE | Substantially Equivalent | |
| K142653 | G-Lok and G-Lok XL Extender | MBI | Substantially Equivalent | |
| K113297 | KNOTILUS ANCHOR SYSTEM | MBI | Substantially Equivalent | |
| K112296 | LATERAL BUTTON | MBI | Substantially Equivalent | |
| K110763 | LATARJET CORTICAL SCREW SET | HWC | Substantially Equivalent | |
| K101616 | THE GRAPPLR AND GRAPPLR EXTENDER | MBI | Substantially Equivalent | |
| K100887 | VERSITOMIC ACL FLEXIBLE REAMER SYSTEM STERILIZATION TRAY | KCT | Substantially Equivalent | |
| K091694 | MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM) | HWC | Substantially Equivalent | |
| K083096 | LATARJET CORTICAL SCREW SET | HWC | Substantially Equivalent | |
| K020705 | SIIS#1 TISSUE SUSPENSION SYSTEM | OTN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8043971 | 1000272060 | T.A.G. MEDICAL PRODUCTS CORPORATION LTD | KIBBUTZ GAATON, GAATON Northern 2513000 IL | 2026 | and 22 more, listed in full below |
| 3022132808 | 3022132808 | T.A.G. MEDICAL PRODUCTS CORPORATION LTD | Harotem 23, Bar-Lev Northern 2015600 IL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NBHAccessories, Arthroscopic
- HWJAwl
- HTWBit, Drill
- GFGBit, Surgical
- GFABlade, Saw, General & Plastic Surgery, Surgical
- HXYBrace, Drill
- GEACannula, Surgical, General & Plastic Surgery
- HXZCutter, Wire
- DZADrill, Dental, Intraoral
- HWBExtractor
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- HTPFile
- DZEImplant, Endosseous, Root-Form
- HXPInstrument, Bending Or Contouring
- MDMInstrument, Manual, Surgical, General Use
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- QBOInstruments Designed For Press-Fit Osteochondral Implants
- DZNInstruments, Dental Hand
- KDDKit, Surgical Instrument, Disposable
- HTSKnife, Orthopedic
- GCJLaparoscope, General & Plastic Surgery
- OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- LXHOrthopedic Manual Surgical Instrument
- HWQPasser
- HXIPasser, Wire, Orthopedic
- HXBProbe
- HXOPusher, Socket
- HTOReamer
- HRRScissors, Orthopedic, Surgical
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- HRTStripper, Surgical
- HWKTrephine
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2065-2023 | Betta Link LG Reusable Fishmouth Guide-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: 110045157 | 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. | Class II | Open, Classified | |
| Z-2064-2023 | Betta Link LG Reusable ProngED Guide - 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: 110045156 | 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. | Class II | Open, Classified | |
| Z-2063-2023 | BETTA LINK SR REUSABLE FISHMOUTH GUIDE-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: 110045151 | 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. | Class II | Open, Classified | |
| Z-2062-2023 | BETTA LINK SR REUSABLE PRONGED GUIDE- 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: 110045150 | 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. | Class II | Open, Classified | |
| Z-2061-2023 | BETTA LINK LG 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: 110045160 | 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. | Class II | Open, Classified | |
| Z-2060-2023 | 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. | Class II | Open, Classified | |
| 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. | Class II | Terminated | |
| Z-0656-2010 | Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair. Catalog Number: SMB000101 | Device failed to deploy the distal loop | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain