BEUDAMED
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    FORZA SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Radius Plate PROlock II

    FDA UDI
    I.T.S. GmbH·09120034307973·Radius Plate PROlock II, 11-Hole, Right

    WIRE CUTTER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896096868·WIRE CUTTER WITH SPRINGS SINGLE ACTION UP-ANGLE...

    Altus Spine Cervical Interbody Fusion System

    FDA UDI
    Altus Spine, LLC·00843210131252·Rasp, W/Tab

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551038795·ROSA BUSHING FOR sEEG, SHORT, FOR 2.1MM DRILL

    NexxZr™ / W-98-10-UT-C200-ML

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271139290·

    Plateau Spacer System

    FDA UDI
    Life Spine, Inc.·00190837027100·PLATEAU Interbody, Curved, Bulleted, 11mm 31mm ...

    EXHALE PROBE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES

    FDA 510(k)
    FDA Class 2 ·Neurology

    NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HRS·April 4, 2023

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code LOX·December 16, 2022

    TREK¿

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·May 27, 2025

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·May 9, 2013

    ARCHITECT I1000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·September 19, 2014

    MALLORY/HEAD PRESS FIT FEMORAL POROUS 16X180MM STEM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LZO·May 25, 2011

    SMR GLENOSPHERE Ø 40MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A·Product code MBF·May 31, 2023

    TREK¿

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·January 7, 2026

    Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Recall
    Terminated ·Carefusion 211 Inc dba Carefusion·Product code CBK·September 5, 2013

    Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·October 9, 2013

    Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surgical procedures performed in a hybrid OR and electrophysiology

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 28, 2021