Tedan Surgical Innovations, LLC
Tedan Surgical Innovations, LLC holds FDA 510(k) medical device clearances, first cleared 2014, most recent 2017, with 13 FDA device recalls on record.
Top product codes for Tedan Surgical Innovations, LLC
FDA recalls by Tedan Surgical Innovations, LLC
10 most recent of 13- Z-2530-2020 — PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
- Z-2527-2020 — PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
- Z-2529-2020 — PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
- Z-2528-2020 — PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
- Z-2524-2020 — 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
- Z-2526-2020 — PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
- Z-2525-2020 — 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
- Z-1845-2020 — Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They are reusable devices that are connected to the hospital suction system to remove debris and blood from the surgical field.
- Z-1503-2020 — D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
- Z-1506-2020 — DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Tedan Surgical Innovations, LLC
Data sourced from openFDA. This site is unofficial and independent of the FDA.