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stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation

FDA Enforcement
Class II ·Ongoing·Wright Medical Technology, Inc.·May 3, 2023

stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation

FDA Enforcement
Class II ·Ongoing·Wright Medical Technology, Inc.·May 3, 2023

CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit

FDA Enforcement
Class II ·Ongoing·Terumo Cardiovascular Systems Corporation·July 2, 2025

Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754

FDA Enforcement
Class II ·Ongoing·Terumo Cardiovascular Systems Corporation·April 9, 2025

Smaxel Fractional CO2 Laser, a Class IV medical laser system.

FDA Enforcement
Class II ·Ongoing·IDS LTD·January 15, 2025

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