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Philips India Limited: FDA-registered device maker in Pune Maharashtra, India, 1 510(k) clearance

Name: Philips India Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Philips India Limited is registered with the FDA (registration 3010685285) in Pune Maharashtra, India. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 5, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010685285
Address: Plot no. B-79, MIDC, Phase-II, Chakan Taluka - khed, Village - Savardari, Pune Maharashtra, India, 410 501
Owner or operator: Philips Medical Systems International BV (1217116)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: February 21, 2006
Registered through: 2026
Brand names listed: BV Endura, BV Pulsera, StentBoost Mobile, Veradius Unity, Zenition 30, Zenition 50, Zenition 70, Zenition 90

Devices it lists

Device	Product code	Class	Role	Source
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Contract manufacturer	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 5, 2021	K203623	StentBoost Mobile	OWB	Substantially Equivalent	Philips India Limited	accessdata.fda.gov

Compare with other makers

Updated April 5, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.