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    ASPIRON ACP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257125205·20-30 MV FOR MEN CLSC CALF STD GREY IV

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776170264·Diethrich Right-Angle Clamp

    Cancellous Screw, Cannulated

    FDA UDI
    I.T.S. GmbH·09120034302411·Cancellous Screw, Cannulated, D=4.0mm, L=34mm, ...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319740484·Bainbridge Intestinal Forceps 7-1/4" (18.4cm), ...

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780379379·Integra® Jarit® Diethrich Clamp, 7", Right Angled

    HISTOACRYL FLEXIBLE PACK 5

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code MPN·December 3, 2019

    HM-LAMP II

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

    LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM

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

    INCLUSIVE TAPERED IMPLANT 3.7 MMD X 10 MML X 3.5 MMP

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·March 20, 2026

    ENDURANT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·May 31, 2013

    UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·June 26, 2011

    GORE HELEX SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES, INC·Product code MLV·August 29, 2008

    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

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·December 11, 2013

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013