BEUDAMED
    19 results · 27ms · Sources: EU EUDAMED, US FDA

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    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112878·CORNEAL TREPHINE BLADE6.5MM

    NextAR TKA Platform

    FDA 510(k)
    FDA Class 2 ·Neurology

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112717·BARRON VACUUM PUNCH 6.5MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112465·BARRON VACUUM TREPHINE 6.5MM

    TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION

    FDA 510(k)
    FDA Class 2 ·Dental

    HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNKNOWN COOL TIP ELECRTRODE

    FDA Adverse Event
    Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·April 27, 2022

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FKX·June 28, 2013

    GE OEC 7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 16, 2008

    HEMOCUE GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Injury ·HEMOCUE AB·Product code LFR·August 5, 2011

    CHLORAPREP UNKNOWN

    FDA Adverse Event
    Injury ·CAREFUSION 213, LLC 0113·Product code KXG·November 15, 2021

    ARCHITECT CA19-9XR REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code NIG·April 27, 2021

    ONYX

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·July 20, 2023

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·June 7, 2021

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·February 18, 2026

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·February 20, 2020

    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

    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