BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    True HD 3MOS Camera System

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

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694032209·1.7mm  Cannulated Drill, Fusion, Quick Release

    OsteoMed

    FDA UDI
    Provision·B504OM31610170·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694040754·PrimaLIF LLIF 17mm x 22mm Lordotic Trial

    Spex

    FDA UDI
    SPEX LIMITED·09420051701229·Footfast Ankle Stabilisers Size Small (Pair)

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694068321·HPS 1.6 Fusion 1.7mm Drill Quick Release Steril...

    ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EASYSPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP.·Product code FPA·July 23, 2014

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JGS·June 17, 2011

    3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and 1.6mm x 12 K-Wire.

    FDA Enforcement
    Class II ·Ongoing·Arthrex, Inc.·November 21, 2018

    Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Model: 781315

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash# Size: Honeywell Part# K206125 LXXV - 75V " Economy Cabinet 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K 206154 LXXV - 75V " Deluxe Cabinet 3 Shelf RS08016 Eye Wash - 4 oz. 32-000452-0000 K206210 FAC- 3 Deluxe Cabinet 3 Shelf R508016 Eye Wash - 4 oz. 32-000452-0000 K606999 ZLBCSX CPR Kit 37 R508016 Eye Wash " 4 oz. 32-000452-0000 KR206152 FAC " 4R 200 Person Deluxe Cabinet - Refill R508016 Eye Wash 4 oz. 32-000452-0000 K608054 Cement Burn Cabinet R511018 Eye Wash " 16 oz. 32-000454 0000- H5 K610045 FAC.3 " Deluxe Cabinet .w/BBP .NO MEDS .3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K606289 Eye Wash Cabinet 316 R511018 Eye Wash - 16oz 32-000454-0000-HS K608061 36MDelmarva Power/ACEw/Logo R508016 Eye Wash4 oz. 32-000452-0000 K611017 16PW " Hospeco " w/logo R508016 Eye Wash " 4 oz. 32-000452-0000 K206152 FAC4 200 Person Deluxe Cabinet 4 Shelf R508016 Eye Wash4 oz. 32-000452-0000 K206140 CLX 100 Person Deluxe Cabinet " 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 KR206210 FAC " 3R " Deluxe Cabinet Refill R508016 Eye Wash " 4 oz 32-000452-0000 K209061 TRMK Trauma Kit with Orange Co-Polymer Case R511018 Eye Wash -16 oz. 32-000454-0000-HS K206130 LXXV7SHStandard Cabinet Swing Out Door2 Shelf R508016 Eye Wash " 4 oz 32-000452-0000 Product Usage: various first aid/emergency kits containing eyewash

    FDA Recall
    Terminated ·Certified Safety Mfg Inc·Product code LRR·March 20, 2018

    First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash# Size: Honeywell Part# K206125 LXXV - 75V " Economy Cabinet 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K 206154 LXXV - 75V " Deluxe Cabinet ¿3 Shelf RS08016 Eye Wash - 4 oz. 32-000452-0000 K206210 FAC- 3 ¿Deluxe Cabinet ¿3 Shelf R508016 Eye Wash - 4 oz. 32-000452-0000 K606999 ZLB¿CSX CPR Kit 37 R508016 Eye Wash " 4 oz. 32-000452-0000 KR206152 FAC " 4R ¿200 Person Deluxe Cabinet - Refill R508016 Eye Wash ¿4 oz. 32-000452-0000 K608054 Cement Burn Cabinet R511018 Eye Wash " 16 oz. 32-000454 0000- H5 K610045 FAC.3 " Deluxe Cabinet .w/BBP .NO MEDS .3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K606289 Eye Wash Cabinet ¿316 R511018 Eye Wash - 16oz 32-000454-0000-HS K608061 36M¿Delmarva Power/ACE¿w/Logo R508016 Eye Wash¿4 oz. 32-000452-0000 K611017 16PW " Hospeco " w/logo R508016 Eye Wash " 4 oz. 32-000452-0000 K206152 FAC¿4 ¿200 Person Deluxe Cabinet ¿4 Shelf R508016 Eye Wash¿4 oz. 32-000452-0000 K206140 CLX ¿100 Person ¿Deluxe Cabinet " 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 KR206210 FAC " 3R " Deluxe Cabinet ¿Refill R508016 Eye Wash " 4 oz 32-000452-0000 K209061 TRMK ¿Trauma Kit with Orange Co-Polymer Case R511018 Eye Wash -16 oz. 32-000454-0000-HS K206130 LXXV¿7SH¿Standard Cabinet Swing Out Door¿2 Shelf R508016 Eye Wash " 4 oz 32-000452-0000 Product Usage: various first aid/emergency kits containing eyewash

    FDA Enforcement
    Class II ·Terminated·Certified Safety Mfg Inc·April 18, 2018

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026