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Lyme Test

FDA Enforcement
Class II ·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025

A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended

FDA Enforcement
Class II ·Ongoing·Genicon, Inc.·November 11, 2020

Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.

FDA Enforcement
Class II ·Ongoing·Brasseler USA I Lp·February 14, 2024

Heraeus, PALAMIX duo. Material Number: 66057897.

FDA Enforcement
Class III ·Ongoing·Heraeus Medical GmbH (Dental Division)·May 6, 2026

Heraeus, PALAMIX uno. Material Number: 66057893.

FDA Enforcement
Class III ·Ongoing·Heraeus Medical GmbH (Dental Division)·May 6, 2026

Philips OMNI II TEE Ultrasound Transducer

FDA Enforcement
Class III ·Ongoing·Philips Ultrasound, Inc·April 1, 2026

Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2

FDA Enforcement
Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026

Philips OMNI III TEE Ultrasound Transducer

FDA Enforcement
Class III ·Ongoing·Philips Ultrasound, Inc·April 1, 2026

Philips X7-2 Ultrasound Transducer

FDA Enforcement
Class III ·Ongoing·Philips Ultrasound, Inc·April 1, 2026

Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1

FDA Enforcement
Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026

Philips S4-1 Ultrasound Transducer

FDA Enforcement
Class III ·Ongoing·Philips Ultrasound, Inc·April 1, 2026

Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT

FDA Enforcement
Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026

Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X

FDA Enforcement
Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026

Philips C9-4 Ultrasound Transducer

FDA Enforcement
Class III ·Ongoing·Philips Ultrasound, Inc·April 1, 2026

Philips L17-5 Ultrasound Transducer

FDA Enforcement
Class III ·Ongoing·Philips Ultrasound, Inc·April 1, 2026

Philips Mini Multi TEE Ultrasound Transducer

FDA Enforcement
Class III ·Ongoing·Philips Ultrasound, Inc·April 1, 2026

Penner Pacific Bathing Spa, Model Numbers 360020-1EP

FDA Enforcement
Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026

Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL

FDA Enforcement
Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026

Philips 3D6-2 Ultrasound Transducer

FDA Enforcement
Class III ·Ongoing·Philips Ultrasound, Inc·April 1, 2026

Penner Pacific Bathing Spa, Model Numbers 360020-1P

FDA Enforcement
Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026