BEUDAMED
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    MAHE FIXATION PLATE AND SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814565·GENUMEDI SAND SIZE V

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964073779·The Endo Carry-on Procedure Kit includes Endo C...

    ACCUPROBE®

    FDA UDI
    Hologic, Inc.·15420045506138·AccuProbe® Mycobacterium avium Complex.

    StarBurst Talon

    FDA UDI
    NAVILYST MEDICAL, INC.·H7877001028451·RITA StarBurst Talon Semi-Flex Electrosurgical ...

    Silex

    FDA UDI
    SILEX MEDICAL, LLC·B331EZL102845·Slide Locking Long Endoclinch Grasping Forceps

    STARBURST SEMI-FLEX 3-5CM, 25CM LENGTH, FLEXIBLE

    FDA Adverse Event
    Injury ·ANGIODYNAMICS·Product code GEI·May 9, 2013

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 18, 2019

    SIMPLICITY SOFT QD MICRO INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PAFLUFOCON C AND E DAILY CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    THERMOPAD

    FDA Adverse Event
    Injury ·ANGIODYNAMICS, INC.·Product code GEI·May 30, 2013

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 9, 2013

    CAD II

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·September 19, 2014

    EON RECHARGEABLE IPG, 16-CHANNEL

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 12, 2011

    MANTIS REDUX BLOCKER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code NKB·November 27, 2019

    Brand Names: Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits Classification Name: Device, Monitoring, Intracranial Pressure 510(k) Number: K102875 The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature. The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space. The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring. The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage. The Camino 110-4L catheter is intended for use with the Licox Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively.

    FDA Recall
    Terminated ·Integra Limited·Product code GWM·September 10, 2013

    Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits Classification Name: Device, Monitoring, Intracranial Pressure 510(k) Number: K102875 The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature.  The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space.  The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring.  The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage.  The Camino 110-4L catheter is intended for use with the Licox¿ Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma.  The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively.

    FDA Enforcement
    Class II ·Terminated·Integra Limited·November 6, 2013

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L101, ESSENTIO DR SL Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025