BEUDAMED
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    IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517635617·CoRoent Ant TLIF PEEK, 10x12x32mm 15°

    JOBST Bella Strong

    FDA UDI
    BSN MEDICAL, INC.·00035664009694·BELLA STRONG 20-30 MM HG ARMSLEEVE KNIT WELT SI...

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·G586G1023250·probe w/ eye, usa pattern, sterling silver, 5 1...

    Diagon

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030MO1023250·Trial, Offset Bi-Convex, 10 x 34mm, 15mm.

    CARDIOVENTION CORX SYSTEM, MODEL FG 0001

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WUJIN #3 TIBIAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2)

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LCP·October 27, 2011

    SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LCP·October 27, 2011

    STELLARIS VISION ENHANCEMENT SYSTEM

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQC·February 5, 2026

    SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LCP·October 27, 2011

    REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·March 19, 2014

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·April 30, 2013

    BA-320-185

    FDA Adverse Event
    Malfunction ·BIOTEX MEDICAL·Product code HOA·August 27, 2014

    GIRAFFE OMNIBED

    FDA Adverse Event
    Death ·OHMEDA MEDICAL·Product code FMZ·May 17, 2011

    ENSEAL GENERIC PRODUCT CODE

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·September 22, 2025

    DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 14, 2018

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

    Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·November 24, 2021

    Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·June 13, 2018