Pulmone Advanced Medical Devices, Ltd.

Raananna Central, IL

PULMONE ADVANCED MEDICAL DEVICES, LTD. appears in FDA device records in Raananna Central, IL. FDA records list 3 510(k) clearances between 2014-05-02 and 2016-10-21, 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 Pulmone Advanced Medical Devices, Ltd. between 2014 and 2016. The busiest year on record is 2014, with 1. The most recent is 2016, with 1.

Clearances by year, as a table

510(k) clearance decisions for Pulmone Advanced Medical Devices, Ltd., by decision year
Year	Clearances
2014	1
2015	1
2016	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K161295	MiniBox +	BZC	Substantially Equivalent	2016-10-21
K141793	PULMONE MINIBOXPFT 2.0	BZG	Substantially Equivalent	2015-03-06
K133051	PULMONE MINIBOX PFT TM	BZC	Substantially Equivalent	2014-05-02

Registered establishments

FDA registered establishments for Pulmone Advanced Medical Devices, Ltd., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3011269086	3011269086	PULMONE ADVANCED MEDICAL DEVICES, LTD.	14 HaMelacha Street, Raananna Central 4366107 IL	2026	BZC BZG

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