BEUDAMED
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    ENZYMATIC BUN (RATE) REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Ceramill

    FDA UDI
    Amann Girrbach AG·E4947612611·

    Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    L4 OXYGEN CONCENTRATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACCU-CHEK COMPACT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·July 23, 2007

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 26, 2012

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·April 21, 2014

    FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND SMALL) -Product numbers 6680217 and 6680221 - Wound Management Product. Indicated for patients who wold benefit from a suction device particularly as the device may promote wound healing.

    FDA Recall
    Terminated ·Smith And Nephew, Inc. Wound Management Division·Product code BTA·March 31, 2008

    RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code OMP·August 13, 2014

    GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED MODEL: GTM21097-5012, Made in China. Indicated for patients who would benefit from a suction device particularly as the device may promote wound healing, including patients who would benefit from vacuum assisted drainage and removal of infectious materials or other fluid from wounds under the influence of continuous pressure.

    FDA Recall
    Terminated ·Smith And Nephew, Inc. Wound Management Division·Product code BTA·August 7, 2008

    RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139

    FDA Recall
    Open, Classified ·Smith & Nephew Medical, Ltd.·Product code OMP·March 11, 2024

    RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140

    FDA Recall
    Open, Classified ·Smith & Nephew Medical, Ltd.·Product code OMP·March 11, 2024

    smith&nephew EZCARE Negative Pressure Rx only. 100-240 V 12 V 50/60 Hz 90VA T1A 250 V Indicated for patients who would benefit from a suction device particularly as the device may promote healing when used with accessory wound sealing kits. Made in USA by/Fabrique aux Etals Unis par: Smith & Nephew, Inc., Largo, FL 33773 Smith & Nephew Medical Limited Hull HU3 2BN England

    FDA Recall
    Terminated ·Smith & Nephew Inc.·Product code OMP·January 29, 2010

    ***REF 66800694***Qty 10***smith&nephew***RENASYS Port Foam Dressing Kit Port***STERILE***Rx Only.***Made in Mexico for/Fabrique au Mexique pour: Smith & Nephew, Inc., St. Petersburg, FL 33716***Smith & Nephew Medical Limited Hull HU3 2BN England***Lot 123456. Product Usage: The product is a suction device used as an accessory to the foam dressing kits, which is used in conjunction with Smith & Nephew Negative Pressure Wound Therapy (NPWT) systems to deliver negative pressure to a wound.

    FDA Recall
    Terminated ·Smith & Nephew Inc.·Product code OMP·December 14, 2010

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025