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    aprevo® anterior lumbar interbody fusion device with interfixation

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Altus Spine Interbody Fusion System

    FDA UDI
    Altus Spine, LLC·00843210131580·Broach Trial

    18M - Class A 21 White Cap - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620091·18M - Class A 21 White Cap - Metal

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193100098·EVOS Straight HA PEEK 9mm x 9mm x 22mm Biconvex...

    G185

    FDA UDI
    RESEARCH INSTRUMENTS LIMITED·05060554120109·Incubator for assisted reproduction

    G185

    FDA UDI
    RESEARCH INSTRUMENTS LIMITED·05060554120116·Incubator for assisted reproduction

    AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Radiology

    3I IMPLANTS; OSSEOTITE DENTAL IMPLANTS; OSSEOTITE NT DENTAL IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER - INTERNATIONAL KIT

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·September 13, 2024

    PROSTIVA

    FDA Adverse Event
    Injury ·MPROC, VILLALBA·Product code KNS·November 6, 2008

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 17, 2011

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 5, 2013

    CASHMERE 14 - PLATINUM MICROCOIL

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code HCG·June 20, 2017

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CODMAN AND SHURTLEFF, INC·Product code NJE·June 20, 2017

    PRESIDIO - CERECYTE MICROCOIL

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code HCG·June 20, 2017

    UNKNOWN CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·June 16, 2017

    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code FMZ·June 30, 2021

    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·August 25, 2021

    LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code JWH·January 22, 2009

    LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.

    FDA Recall
    Terminated ·Smith & Nephew Inc·Product code JWH·January 22, 2009