Synaptive Medical, Inc.
Synaptive Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 2014, most recent 2024, with 5 FDA device recalls on record.
Top product codes for Synaptive Medical, Inc.
FDA recalls by Synaptive Medical, Inc.
- Z-1955-2021 — Synaptive Trackable Suction Set Standard and Malleable
- Z-1758-2020 — ClearCanvas RIS/PACS
- Z-1759-2020 — Synaptive ImageDrive Clinical
- Z-0470-2019 — BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath only / sheath and obturator), the tip of the obturator is represented in the software with a tip extension beyond the bottom of the sheath. Note sheath and cannula are used interchangeably in this document.
- Z-0480-2016 — Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.
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 Synaptive Medical, Inc.
- K231986 — Modus IR
- K232981 — Synq Software Version 1.3
- K200327 — Evry
- K183325 — Modus Nav
- K180394 — BrightMatter Plan 1.6.0
- K160523 — BrightMatter Guide with BrightMatter Pointer
- K153281 — BrightMatter Guide with Surface Trace Registration
- K153284 — Synaptive ImageDrive Pro
- K142024 — BRIGHTMATTER NAVIGATION SYSTEM
- K140337 — BRIGHTMATTER PLANNING SOFTWARE
Data sourced from openFDA. This site is unofficial and independent of the FDA.