PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. vs Roen Health, Inc. dba RoenRx: FDA Enforcement Comparison

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has been the subject of 205 FDA enforcement/approval records tracked by Argus HQ, compared to 1 for Roen Health, Inc. dba RoenRx.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: 0 warning letters, 205 recalls, 0 approval records, 0 Form 483s.

Roen Health, Inc. dba RoenRx: 1 warning letter, 0 recalls, 0 approval records, 0 Form 483s.

Side by side

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Warning letters0

Roen Health, Inc. dba RoenRx — Warning letters1

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Recalls205

Roen Health, Inc. dba RoenRx — Recalls0

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Approval records0

Roen Health, Inc. dba RoenRx — Approval records0

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Form 483s0

Roen Health, Inc. dba RoenRx — Form 483s0

Timeline

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Most recent FDA action: August 19, 2026

Full history →

Roen Health, Inc. dba RoenRx

Most recent FDA action: June 8, 2026

Full history →

Cite this comparison

Pre-formatted for a story, footnote, or reference list:

"PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. vs Roen Health, Inc. dba RoenRx: FDA Enforcement Comparison." Argus HQ, accessed August 27, 2026. https://argushq.ai/compare/philips-medical-systems-nederland-b-v-vs-roen-health-inc-dba-roenrx

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗