BEUDAMED
    1,033 results · 16ms · Sources: EU EUDAMED, US FDA

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    GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 2082844-001-01040418; 2) 2082844-001-01046784; 3) 2082844-001-01052324; 4) 2082844-001-01052572; 5) 2082844-001-01055337; 6) 2082844-001-01065693; 7) 2082844-001-01069008; 8) 2082844-001-01073750; 9) 2082844-001-01086553; 10) 2082844-001-01089393; 11) 2082844-001-01090414; 12) 2082844-001-01092632; 13) 2082844-001-01111482; 14) 2082844-001-01115741; 15) 2082844-001-01122391; 16) 2082844-001-01128579; 17) 2082844-001-01128725; 18) 2082844-001-01131573; 19) 2082844-001-01140642; 20) 2082844-001-01165870; 21) 2082844-001-100397; 22) 2082844-001-100676; 23) 2082844-001-100740; 24) 2082844-001-100743; 25) 2082844-001-100744; 26) 2082844-001-101075; 27) 2082844-001-101149; 28) 2082844-001-101199; 29) 2082844-001-101202; 30) 2082844-001-101203; 31) 2082844-001-101356; 32) 2082844-001-101366; 33) 2082844-001-101656; 34) 2082844-001-102136; 35) 2082844-001-102589; 36) 2082844-001-102858; 37) 2082844-001-526493; 38) 2082844-001-533346; 39) 2082844-001-570904; 40) 2082844-001-615985; 41) 2082844-001-616544; 42) 2082844-001-674814; 43) 2082844-001-701655; 44) 2082844-001-704407; 45) 2082844-001-709042; 46) 2082844-001-857748; 47) 2082844-001-888278; 48) 2082844-001-941288; 49) 2082844-001-965539; 50) 2082844-001-978713; 51) 2082844-001-982099; 52) 2082844-001-982310; 53) 2082844-001-982985; 54) 2082844-001-982988; 55) 2082844-001-983509; 56) 2082844-001-983643; 57) 2082844-001-983679; 58) 2082844-001-984096; 59) 2082844-001-984948; 60) 2082844-001-987480; 61) 2082844-001-987855; 62) 2082844-001-993967; 63) 2082844-001-994441; 64) 2082844-001-995782; 65) 2082844-001-998377; Radiant infant warmer

    FDA Enforcement
    Class I ·Completed·DATEX--OHMEDA, INC.·November 6, 2024

    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument

    FDA Enforcement
    Class II ·Completed·Beckman Coulter, Inc.·February 12, 2025

    iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.

    FDA Enforcement
    Class III ·Completed·Iotamotion Inc·November 13, 2024

    GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 2082844-002-01093489; 9) 2082844-002-01113262; 10) 2082844-002-01113711; 11) 2082844-002-01123085; 12) 2082844-002-01123918; 13) 2082844-002-01128966; 14) 2082844-002-01133042; 15) 2082844-002-01146447; 16) 2082844-002-100205; 17) 2082844-002-100749; 18) 2082844-002-100752; 19) 2082844-002-100995; 20) 2082844-002-101425; 21) 2082844-002-523548; 22) 2082844-002-529928; 23) 2082844-002-594800; 24) 2082844-002-643544; 25) 2082844-002-925841; 26) 2082844-002-965540; 27) 2082844-002-982916; 28) 2082844-002-983420; 29) 2082844-002-993905; 30) 2082844-002-995018; 31) 2082844-002-995799; 32) 2082844-002-998943; Radiant infant warmer

    FDA Enforcement
    Class I ·Completed·DATEX--OHMEDA, INC.·November 6, 2024

    Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00

    FDA Enforcement
    Class II ·Completed·Spectrum Medical Ltd.·October 30, 2024

    Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Number: 1159851 Cardinal Catalog Number: 8881560125

    FDA Enforcement
    Class II ·Completed·Mckesson Medical-Surgical Inc. Corporate Office·June 19, 2024

    Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.

    FDA Enforcement
    Class II ·Completed·Percussionaire Corporation·November 15, 2023

    The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.

    FDA Enforcement
    Class II ·Completed·Abbott Molecular, Inc.·August 24, 2022

    ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

    FDA Enforcement
    Class II ·Completed·Materialise USA LLC·August 31, 2022

    SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.

    FDA Enforcement
    Class II ·Completed·SAFE ORTHOPAEDICS LLC·August 31, 2022

    Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.

    FDA Enforcement
    Class II ·Completed·Shippert Medical Technologies·May 22, 2019

    1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System

    FDA Enforcement
    Class II ·Completed·New Standard Device Inc·June 15, 2022

    Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.

    FDA Enforcement
    Class II ·Completed·Lens.com·December 11, 2019

    Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

    FDA Enforcement
    Class I ·Completed·Ethicon Endo-Surgery Inc·May 22, 2019

    Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.

    FDA Enforcement
    Class II ·Completed·Shippert Medical Technologies·May 22, 2019

    Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

    FDA Enforcement
    Class I ·Completed·Ethicon Endo-Surgery Inc·May 22, 2019

    Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the anvil shaft in a location remote from the main body of the instrument to improve access and visibility.

    FDA Enforcement
    Class I ·Completed·Ethicon Endo-Surgery Inc·May 22, 2019

    Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.

    FDA Enforcement
    Class II ·Completed·Shippert Medical Technologies·May 22, 2019

    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

    FDA Enforcement
    Class II ·Completed·Encore Medical, Lp·April 4, 2018

    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

    FDA Enforcement
    Class II ·Completed·Encore Medical, Lp·April 4, 2018