Liofilchem, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Liofilchem, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Ceftobiprole BPR 5 µg Disc
2
Total
2
Cleared
0
Denied
Liofilchem, Inc. has 2 FDA 510(k) cleared medical devices. Based in Waltham, US.
Latest FDA clearance: Jul 2026. Active since 2025. Primary specialty: Microbiology.
Browse the FDA 510(k) cleared devices submitted by Liofilchem, Inc. Filter by specialty or product code using the sidebar.
1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Liofilchem, Inc.
2 devices