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ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.

FDA Enforcement
Class II ·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012

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

Penner Pacific Bathing Spa, Model Numbers 860010-1L

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

Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X

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