Orsense Ltd

Tel Aviv Yafo Central, IL

ORSENSE LTD appears in FDA device records in Tel Aviv Yafo Central, IL. FDA records list 3 510(k) clearances between 2010-03-19 and 2015-01-16, no PMA records and one registered establishment. 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: 1

510(k) clearance history

FDA records hold 3 510(k) clearances for Orsense Ltd between 2010 and 2015. The busiest year on record is 2010, with 1. The most recent is 2015, with 1.

Clearances by year, as a table

510(k) clearance decisions for Orsense Ltd, by decision year
Year	Clearances
2010	1
2013	1
2015	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K142209	Pulse oximeter NBM-200	DQA	Substantially Equivalent	2015-01-16
K124041	NBM-200MP	DQA	Substantially Equivalent	2013-10-17
K091564	NBM-200MP PULSE OXIMETRY DEVICE	DQA	Substantially Equivalent	2010-03-19

Registered establishments

FDA registered establishments for Orsense Ltd, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3007358963	3007358963	ORSENSE LTD	6 Ha'Nechoshet Street, Tel Aviv Yafo Central 6971070 IL	2026	DQA GLY QGU

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