BEUDAMED
    28 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY" Delivery System Model DIB00 contains the TECNISEyhance" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. Component: No

    FDA Enforcement
    Class II ·Ongoing·AMO Puerto Rico Manufacturing, Inc.·April 1, 2026

    TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only

    FDA Enforcement
    Class II ·Ongoing·Johnson & Johnson Surgical Vision, Inc.·August 9, 2023

    TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only

    FDA Enforcement
    Class II ·Ongoing·Johnson & Johnson Surgical Vision, Inc.·August 9, 2023

    Pentacam HR REF 70900. Used to image the anterior segment of the eye.

    FDA Enforcement
    Class II ·Ongoing·Oculus Optikgeraete GMBH·September 7, 2022

    RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE: +21.00D, Sph: +21.00D.

    FDA Enforcement
    Class II ·Ongoing·Rayner Intraocular Lenses Ltd·July 13, 2022

    Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.

    FDA Enforcement
    Class II ·Ongoing·Oculus Optikgeraete GMBH·September 7, 2022

    TECNIS Toric II OptiBlue IOL Models ZCW

    FDA Enforcement
    Class II ·Ongoing·Johnson & Johnson Surgical Vision, Inc.·January 24, 2024

    Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker

    FDA Enforcement
    Class II ·Ongoing·Vortex Surgical Inc.·February 11, 2026

    Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.

    FDA Enforcement
    Class II ·Ongoing·Oculus Optikgeraete GMBH·September 7, 2022

    Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery cartridge Lens Guide, Intraocular Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·January 22, 2025

    Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

    FDA Enforcement
    Class II ·Ongoing·Alcon Research LLC·July 24, 2024

    a. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 3.5ML PLAS VACUTAINER (100/BX), Model Number: 367983. b. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY8.5ML PLAS VACUTAINER (100/BX Model Number: 367988. c. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP GLD 5MLPLAS VACUTAINER (100/BX) Model Number: 367986. d. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY7.5ML PLAS VACUTAINER (100/BX) Model Number: 367987. e. BECTON DICKINSON BD Vacutainer SST TUBE, BLD COL CLOT/SEP RED/GRY3.5ML PLAS VACUTAINER (100/BX Model Number: 367981. f. BECTON DICKINSON BD Vacutainer TUBE, BLD COL PLAIN RED 10ML GLS VACUTAINER (100/BX 10BX/CS) Model Number: 366430. g. BECTON DICKINSON BD Microtainer SST - Amber TUBE, CAPILLARY CLOT/SEP GLD 400/600UL PLAS MICROT (50/BX) Model Number: 365978. h. BECTON DICKINSON BD Vacutainer CPT NC: 1.0mL FICOLL: 2.0mL TUBE, BLD CPT SOD CIT 8ML (60/CS) Model Number: BD 362761. i. BECTON DICKINSON BD Vacutainer Rapid Serum Tube (RST) Thrombin TUBE, BLD COL CLOT ORG 5ML PETVACUTAINER (100/BX 10BX/CS) Model Number: 368774. j. BECTON DICKINSON BD Vacutainer Buff. Na Citrate 0.109M, 3.2% TUBE, BLD COL SODCIT LTBLU 2.7ML PLAS VACUTAINER (100/BX) Model Number: 363083.

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022

    IBA Proton Therapy System - PROTEUS 235

    FDA Enforcement
    Class II ·Ongoing·Ion Beam Applications S.A.·March 18, 2026

    Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET, UPC 810018098605; 3) SOL-M 60ml Eccentric Tip Syringe w/o Needle, Model No. P180060ET, UPC 810018098698;

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024

    Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024

    Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554; c) SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1" (low dead space), Model No. 181023L, UPC Sold in Canada Only; d) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8" low dead space), Model No. 12558LDS, UPC 810062435319; e) SOL-M 1ml Luer Lock Syringe w/o Needle (PP) (low dead space), Model No. P180001PP, UPC 818392018165; f) SOL-M 1ml TB Slip Tip Syringe w/Exch Needle 25G*5/8'' (low dead space), Model No. 181025S, UPC Sold in Canada Only

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024

    Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC 818392019865; 3) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 12510SN, UPC 818392018851; 4) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model No. 12558SN, UPC 818392018950; 5) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 27G*1/2 (needle aside), Model No. 12705SN, UPC 818392018967; 6) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 30G*1/2 (needle aside), Model No. 13005SN, UPC 818392018974; 7) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 (needle aside), Model No. 32110SN, UPC 818392019001; 8) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 32115SN, UPC 818392019018; 9) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 (needle aside), Model No. 32210SN, UPC 818392019025; 10) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 32215SN, UPC 818392019032; 11) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 23G*1 (needle aside), Model No. 32310SN, UPC 818392019049; 12) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 32510SN, UPC 818392019063; 13) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024

    Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024

    Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523; 3) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. 180020ST, UPC 840368511998; 4) SOL-M 3ml Slip Tip Syringe w/o Needle, Model No. P180003ST, UPC 810018097493; 5) SOL-M 5ml Slip Tip Syringe w/o Needle, Model No. P180005ST, UPC 810018097462; 6) SOL-M 10ml Slip Tip Syringe w/o Needle, Model No. P180010ST, UPC 810018097646; 7) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. P180020ST, UPC 810018098636; 8) SOL-M 30ml Slip Tip Syringe w/o Needle, Model No. P180030ST, UPC 810062435333; 9) SOL-M 60ml Slip Tip Syringe w/o Needle, Model No. P180060ST, UPC 810062435340; 10) SOL-M 1ml Slip Tip Syringe Sterile Convenience Tray, Model No. P180011T, UPC 810018098957

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024

    IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions

    FDA Enforcement
    Class II ·Ongoing·Ion Beam Applications S.A.·September 18, 2024