Naviswiss AG

Brugg Aargau, CH

NAVISWISS AG appears in FDA device records in Brugg Aargau, CH. FDA records list 3 510(k) clearances between 2020-06-10 and 2023-01-31, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show no recalls for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 0
Registered establishments: 2

510(k) clearance history

FDA records hold 3 510(k) clearances for Naviswiss AG between 2020 and 2023. The busiest year on record is 2020, with 1. The most recent is 2023, with 1.

Clearances by year, as a table

510(k) clearance decisions for Naviswiss AG, by decision year
Year	Clearances
2020	1
2021	1
2023	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K223351	Naviswiss Knee	OLO	Substantially Equivalent	2023-01-31
K211429	NAVIPLAN - CT Planning Software for Total Hip Replacement	LLZ	Substantially Equivalent	2021-10-05
K193094	Naviswiss Hip Navigation System	OLO	Substantially Equivalent	2020-06-10

Registered establishments

FDA registered establishments for Naviswiss AG, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3017123055	3017123055	NAVISWISS AG	stahlrain 2, Brugg Aargau 5200 CH	2026	LLZ OLO
3017123056	3017123056	Naviswiss Inc.	3513 Brighton Blvd., Commerce City, CO 80216 US	2026	No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain