BEUDAMED
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    BODY COMPOSITION ANALYZER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017750·K-Wire, Double Ended, Trocar Point, Diameter 0....

    SSW CARBIDE

    FDA UDI
    Ss White Burs, Inc.·D6901400452·FG SL CARBIDE 4 - 5 PACK

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180134973·ELMED REUSABLE MONOPOLAR ELECTRODES - ROLLERBAL...

    Flexor

    FDA UDI
    COOK INCORPORATED·00827002461697·Flexor, Ureteral Access Sheath with AQ, Hydroph...

    Apelo® / Apelo® MIS

    FDA UDI
    ATLAS SPINE, INC.·M68111001400450·5.5mm x 45mm MIS Straight Rod

    Momentum

    FDA UDI
    Ulrich Medical Usa, Inc.·00814386025676·Tap, Ø 4.5mm, cannulated, 1/4"-square

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197389594·ArthVIEW® Arthroscope 45° di...

    OCTO

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Flexor Parallel

    FDA UDI
    COOK INCORPORATED·00827002564428·Flexor, Parallel Rapid Release Ureteral Access ...

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2025

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC·Product code CBK·May 29, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 25, 2011

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code LWR·August 27, 2008

    FLEXOR URETERAL ACCESS SHEATH AND DILATORS

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FED·January 7, 2020

    FLEXOR URETERAL ACCESS SHEATH AND DILATORS

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KOE·August 7, 2018

    UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KOB·May 2, 2018

    CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Skeletal Kinetics, Llc·July 22, 2020

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014