FDA Device Entity Profile: Philips Medical Systems, Inc.

Known Identifiers & Locations

FEI Numbers 1218950

Owner Operator Numbers N/A

Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K982706	PHILIPS BV300 SERIES RELEASE 2.1	1998-09-02	Substantially Equivalent	View Details

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0022-2015	Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system Reason: Philips had discovered through a field service testing where a device failed to comply with a Federal standard.	2014-08-08	Terminated	View Details

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