BEUDAMED
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    SIGNA HI SPEED 1.5T

    FDA Adverse Event
    Other ·GE MEDICAL SYSTEMS, LLC·Product code LNG·July 7, 2006

    REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    FDA Adverse Event
    Malfunction ·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code FRN·February 3, 2026

    SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handpiece connections. The Micadent is used to perform intra¿ oral air abrasion procedures including etching and preparing surfaces for composite restoration. The SEAC Advanced Dental System is substantially similar in design and functions as the SEAC Mobile Dental System manufactured by ASI Medical, Inc. The Micadent is manufactured by Medidents and will be supplied to ASIas a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation. It is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.

    FDA Enforcement
    Class II ·Terminated·ASI Medical, Inc.·December 25, 2013

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    FDA Adverse Event
    Malfunction ·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code QJY·January 29, 2026

    Advance Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile, Manufactured by Advance Medical Designs, Inc., 1241 Atlanta Industrial Drive, Marietta, GA 80066 USA.

    FDA Recall
    Terminated ·Advance Medical Designs Inc·Product code JAA·June 18, 2004

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    FDA Adverse Event
    Malfunction ·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code QJY·March 26, 2026

    SIGNA LX 1.5T

    FDA Adverse Event
    Other ·GE MEDICAL SYSTEMS, LLC·Product code LNH·October 4, 2006

    Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and provides clinically accepted volumetric accuracy for all standard IV fluids, including blood, lipid, and Total Parenteral Nutrition (TPN). Model number: 621-300ES and 621-400ES. To deliver a broad range of drugs with use with the B. Braun Medical Inc. Horizon Pump IV Sets.

    FDA Enforcement
    Class I ·Terminated·B Braun Medical, Inc.·September 25, 2013

    REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    FDA Adverse Event
    Malfunction ·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code FRN·January 27, 2026

    DELTAPAQ CERE 2MMX6CM

    FDA Adverse Event
    Malfunction ·REFER TO SECTION H10·Product code HCG·April 23, 2018

    REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    FDA Adverse Event
    Malfunction ·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code FRN·February 26, 2026

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    FDA Adverse Event
    Malfunction ·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code QJY·March 31, 2026

    REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    FDA Adverse Event
    Malfunction ·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code FRN·January 28, 2026

    Model # 720088-01: AMS AdVance Male Sling System, US; Model # 720088-02: AMS AdVance Male Sling System, INTL; Model # 72404224: Male TO Sling System, INTL. Sterilization Method ETO, American Medical systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA

    FDA Recall
    Terminated ·American Medical Systems, Inc.·Product code FTL·September 7, 2010

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    FDA Adverse Event
    Malfunction ·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code QJY·April 16, 2026

    REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    FDA Adverse Event
    Death ·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code FRN·April 2, 2026

    EON IMPLANTABLE PULSE GENERATOR

    FDA Adverse Event
    Other ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·October 16, 2007

    G2 HELICAL XTRASOFT COIL 2X4

    FDA Adverse Event
    Malfunction ·REFER TO SECTION H10·Product code KRD·August 20, 2018

    EON IMPLANTABLE PULSE GENERATOR

    FDA Adverse Event
    Other ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·October 3, 2007

    ANS QUATTRODE LEAD

    FDA Adverse Event
    Other ·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code GZB·September 7, 2007