FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria

NDA and BLA Calendar Year Approvals

Medline is recalling certain Medline Kits containing recalled Medtronic DLP Left Heart Vent Catheters as the catheter may not retain its shape.

Catalent Indiana LLC, Bloomington, IN 483 Issued 07/14/2025

FDA is conducting a MIDD Pilot Program to facilitate the development and application of exposure-based, biological, and statistical models derived from preclinical and clinical data sources, referred to as MIDD approaches.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 02/17/2023
Short Title (70 char) BlendHouse LLC. Reading, PA. 483 issued 02/17/2023
FEI Number 3015728839
Firm Name BlendHouse LLC
Record Type 483
State PA
Establishment Type Manufacturer