Ninepoint Medical, Inc.
Ninepoint Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2019, with 1 FDA device recall on record.
Top product codes for Ninepoint Medical, Inc.
FDA recalls by Ninepoint Medical, Inc.
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 Ninepoint Medical, Inc.
- K191117 — NvisionVLE Low-profile Optical Probe
- K182616 — NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
- K182261 — NvisionVLE Imaging System, NvisionVLE Optical Probe
- K153479 — NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
- K143678 — NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
- K120800 — NVISION VLE IMAGING SYSTEM
- K121195 — NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
- K112770 — NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.