BEUDAMED
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    Filters Classification: Class Iii × Status: Ongoing × Clear all

    Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 12mm L, 7mm H, Parallel; 37-3108SP 12mm W X 12mm L, 8mm H, Parallel; 37-3109SP 12mm W X 12mm L, 9mm H, Parallel; 37-3110SP 12mm W X 12mm L, 10mm H, Parallel; 37-3111SP 12mm W X 12mm L, 11mm H, Parallel; 37-3112SP 12mm W X 12mm L, 12mm H, Parallel; 37-3113SP 12mm W X 12mm LW, 13mm H, Parallel; 37-3114SP 12mm W X 12mm WL, 14mm H, Parallel; 37-3006SP 12mm W X 12mm L, 6mm H, 5¿ Lordotic; 37-3007SP 12mm W X 12mm L, 7mm H, 5¿ Lordotic; 37-3008SP 12mm W X 12mm L, 8mm H, 5¿ Lordotic; 37-3009SP 12mm WL X 12mm L, 9mm H, 5¿ Lordotic; 37-3010SP 12mm W X 12mm L, 10mm H, 5¿ Lordotic; 37-3011SP 12mm W X 12mm L, 11mm H, 5¿ Lordotic; 37-3012SP 12mm W X 12mm L, 12mm H, 5¿ Lordotic; 37-3013SP 12mm W X 12mm L, 13mm H, 5¿ Lordotic; 37-3014SP 12mm W X 12mm L, 14mm H, 5¿ Lordotic; 37-3207SP 12mm W X 12mm L, 7mm H, 10¿ Lordotic; 37-3208SP 12mm W X 12mm L, 8mm H, 10¿ Lordotic; 37-3209SP 12mm W X 12mm L, 9mm H, 10¿ Lordotic; 37-3210SP 12mm W X 12mm L, 10mm H, 10¿ Lordotic; 37-3211SP 12mm W X 12mm L, 11mm H, 10¿ Lordotic; 37-3212SP 12mm W X 12mm L, 12mm H, 10¿ Lordotic; 37-4106SP 15mm W X 12mm L, 6mm H, Parallel; 37-4107SP 15mm W X 12mm L, 7mm H, Parallel; 37-4108SP 15mm W X 12mm L, 8mm H, Parallel; 37-4109SP 15mm W X 12mm L, 9mm H, Parallel; 37-4110SP 15mm W X 12mm L, 10mm H, Parallel; 37-4111SP 15mm W X 12mm L, 11mm H, Parallel; 37-4112SP 15mm W X 12mm L, 12mm H, Parallel; 37-4113SP 15mm W X 12mm L, 13mm H, Parallel; 37-4114SP 15mm W X 12mm L, 14mm H, Parallel; 37-4006SP 15mm W X 12mm L, 6mm H, 5¿ Lordotic; 37-4007SP 15mm W X 12mm L, 7mm H, 5¿ Lordotic; 37-4008SP 15mm W X 12mm L, 8mm H, 5¿ Lordotic; 37-4009SP 15mm W X 12mm L, 9mm H, 5¿ Lordotic; 37-4010SP 15mm W X 12mm L, 10mm H, 5¿ Lordotic; 37-4011SP 15mm W X 12mm L, 11mm H, 5¿ Lordotic; 37-4012SP 15mm W X 12mm L, 12mm H, 5¿ Lordotic; 37-4013SP 15mm W X 12mm L, 13mm H, 5¿ Lordotic; 37-4014SP 15mm W X 12mm L, 14mm H, 5¿ Lordotic; 37-4207SP 15mm W X 12mm L, 7mm H, 10¿ Lordotic; 37-4208SP 15mm W X 12mm L, 8mm H, 10¿ Lordotic; 37-4209SP 15mm W X 12mm L, 9mm H, 10¿ Lordotic; 37-4210SP 15mm W X 12mm L, 10mm H, 10¿ Lordotic; 37-4211SP 15mm W X 12mm L, 11mm H, 10¿ Lordotic; 37-4212SP 15mm W X 12mm L, 12mm H, 10¿ Lordotic; 37-5106SP 15mm W X 15mm L, 6mm H, Parallel; 37-5107SP 15mm W X 15mm L, 7mm H, Parallel 37-5108SP 15mm W X 15mm L, 8mm H, Parallel; 37-5109SP 15mm W X 15mm L, 9mm H, Parallel; 37-5110SP 15mm W X 15mm L, 10mm H, Parallel; 37-5111SP 15mm W X 15mm L, 11mm H, Parallel; 37-5112SP 15mm W X 15mm L, 12mm H, Parallel; 37-5113SP 15mm W X 15mm L, 13mm H, Parallel; 37-5114SP 15mm W X 15mm L, 14mm H, Parallel; 37-5006SP 15mm W X 15mm L, 6mm H, 5¿ Lordotic; 37-5007SP 15mm W X 15mm L, 7mm H, 5¿ Lordotic; 37-5008SP 15mm W X 15mm L, 8mm H, 5¿ Lordotic; 37-5009SP 15mm W X 15mm L, 9mm H, 5¿ Lordotic; 37-5010SP 15mm W X 15mm L, 10mm H, 5¿ Lordotic; 37-5011SP 15mm W X 15mm L, 11mm H, 5¿ Lordotic; 37-5012SP 15mm W X 15mm L, 12mm H, 5¿ Lordotic; 37-5013SP 15mm W X 15mm L, 13mm H, 5¿ Lordotic; 37-5014SP 15mm W X 15mm L, 14mm H, 5¿ Lordotic; 37-5207SP 15mm W X 15mm L, 7mm H, 10¿ Lordotic; 37-5208SP 15mm W X 15mm L, 8mm H, 10¿ Lordotic; 37-5209SP 15mm W X 15mm LW, 9mm H, 10¿ Lordotic; 37-5210SP 15mm W X 15mm L, 10mm H, 10¿ Lordotic; 37-5211SP 15mm W X 15mm L, 11mm H, 10¿ Lordotic; 37-5212SP 15mm W X 15mm L, 12mm H, 10¿ Lordotic;

    FDA Enforcement
    Class III ·Ongoing·Orthofix U.S. LLC·December 17, 2025

    Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5¿ Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5¿ Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5¿ Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5¿ Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5¿ Lordotic 37-6007SP 12mm W X 12mm L, 7mm H, 5¿ Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5¿ Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5¿ Lordotic 37-6008SP 12mm W X 12mm L, 8mm H, 5¿ Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5¿ Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5¿ Lordotic 37-6009SP 12mm W X 12mm L, 9mm H, 5¿ Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5¿ Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5¿ Lordotic 37-6010SP 12mm W X 12mm L, 10mm H, 5¿ Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5¿ Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5¿ Lordotic 37-6011SP 12mm W X 12mm L, 11mm H, 5¿ Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5¿ Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5¿ Lordotic 37-6012SP 12mm W X 12mm L, 12mm H, 5¿ Lordotic 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6105SP 12mm W X 12mm L, 5mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6106SP 12mm W X 12mm L 6mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6107SP 12mm W X 12mm L, 7mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6108SP 12mm W X 12mm L, 8mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6109SP 12mm W X 12mm L, 9mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6110SP 12mm W X 12mm L, 10mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6111SP 12mm W X 12mm L, 11mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6112SP 12mm W X 12mm L, 12mm H, Parallel 37-6206SP 12mm W X 12mm L, 6mm H, 10¿ Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10¿ Lordotic 37-6206SP 12mm W X 12mm L, 6mm H, 10¿ Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10¿ Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10¿ Lordotic 37-6207SP 12mm W X 12mm L, 7mm H, 10¿ Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10¿ Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10¿ Lordotic 37-6208SP 12mm W X 12mm L, 8mm H, 10¿ Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10¿ Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10¿ Lordotic 37-6209SP 12mm W X 12mm L, 9mm H, 10¿ Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10¿ Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10¿ Lordotic 37-6210SP 12mm W X 12mm L, 10mm H, 10¿ Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10¿ Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10¿ Lordotic 37-6211SP 12mm W X 12mm L, 11mm H, 10¿ Lordotic

    FDA Enforcement
    Class III ·Ongoing·Orthofix U.S. LLC·December 17, 2025

    Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.

    FDA Enforcement
    Class III ·Ongoing·AMS Diagnostics, LLC·July 19, 2017

    WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM

    FDA Enforcement
    Class III ·Ongoing·Straumann USA LLC·February 18, 2026

    Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNOSTIC USE, Store at 2 to 8 C, 0011724/14(3)

    FDA Enforcement
    Class III ·Ongoing·Helena Laboratories, Corp.·December 4, 2019

    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