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

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    Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. It is 75% filled by weight, 52% filled by volume with 0.7 m average particle size. Dentin Shades: fluorescent properties to replicate natural dentin. Available in 18 dentin shades. Enamel Shades: opalescent properties to replicate enamel. Available in 16 enamel shades including pearl, translucent, and opaque shades. Component: N/A

    FDA Recall
    Open, Classified ·Ultradent Products, Inc.·Product code EBF·August 2, 2024

    Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 m (by weight) with narrow upper limit particle distribution. Component: N/A

    FDA Recall
    Open, Classified ·Ultradent Products, Inc.·Product code EBF·August 2, 2024

    Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 m (by weight) with narrow upper limit particle distribution. Component: N/A

    FDA Recall
    Open, Classified ·Ultradent Products, Inc.·Product code EBF·August 2, 2024

    VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.

    FDA Recall
    Open, Classified ·LivaNova USA Inc·Product code LYJ·February 4, 2020

    Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053

    FDA Recall
    Open, Classified ·AtriCure, Inc.·Product code GEH·November 28, 2023

    Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056

    FDA Recall
    Open, Classified ·AtriCure, Inc.·Product code GEH·November 28, 2023

    VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly

    FDA Recall
    Open, Classified ·LivaNova USA Inc·Product code LYJ·November 16, 2018

    KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.

    FDA Recall
    Open, Classified ·Klinika Mdical Gmb Achtzehnmorgenweg 6 Usingen Germany·Product code FMH·April 4, 2025

    KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.

    FDA Recall
    Open, Classified ·Klinika Mdical Gmb Achtzehnmorgenweg 6 Usingen Germany·Product code FMH·April 4, 2025

    POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N

    FDA Recall
    Open, Classified ·SURGICAL SPECIALTIES·Product code GAM·March 26, 2024

    MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 MCP426H13 MCP427H13 MCP4423H16 MCP4424H14 MCP442H14 MCP496H16 MCP497H16 MCP604H13 MCP936H13 MCP945H14 MCPB346H13

    FDA Recall
    Open, Classified ·Ethicon, Inc.·Product code GAM·May 10, 2024

    VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H J345H J370H J416H J417H J426H J427H J458H J493H J603H J699H J936H J978H

    FDA Recall
    Open, Classified ·Ethicon, Inc.·Product code GAM·May 10, 2024

    Hobbs Transbronchial Aspiration Needle Catalog Number: 4621

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code GAA·July 29, 2022

    STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12

    FDA Recall
    Open, Classified ·Ethicon, Inc. Us·Product code GAM·September 20, 2022

    PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.

    FDA Recall
    Open, Classified ·Preat Corp·Product code EMA·February 1, 2023

    STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412

    FDA Recall
    Open, Classified ·Ethicon, Inc.·Product code GAM·March 8, 2024

    VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB946H

    FDA Recall
    Open, Classified ·Ethicon, Inc.·Product code GAM·May 10, 2024

    IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement

    FDA Recall
    Open, Classified ·Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany·Product code EMA·January 25, 2024

    Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code GAA·July 29, 2022

    Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/15, Length 150 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/20, Length 200 mm, Diameter 18 G (1.25 mm); Article no. BIM 16/10, Length 100 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/15, Length 150 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/20, Length 200 mm, Diameter 16 G (1.6 mm); Article no. BIM 14/10, Length 100 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/15, Length 150 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/20, Length 200 mm, Diameter 14 G (2.1 mm) *NOT DISTRIBUTED WITHIN THE US

    FDA Recall
    Open, Classified ·INNOVATIVE TOMOGRAPHY PRODUCT GMBH Universitatsstr. 136 Bochum Germany·Product code GAA·April 21, 2021