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

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015

    Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23

    FDA Enforcement
    Class II ·Ongoing·LimFlow, Inc.·February 4, 2026

    Pediatric Craniotome Ref:CRANI-P-G1

    FDA Enforcement
    Class II ·Ongoing·The Anspach Effort, Inc.·January 18, 2023

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

    FDA Enforcement
    Class II ·Ongoing·SURGICAL SPECIALTIES·April 24, 2024

    Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970

    FDA Enforcement
    Class II ·Ongoing·CP Medical Inc·December 18, 2019

    BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·February 8, 2023

    STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].

    FDA Enforcement
    Class II ·Ongoing·Ethicon, Inc.·May 18, 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 Enforcement
    Class II ·Ongoing·Ethicon, Inc.·November 9, 2022

    AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L UPN: H78712740000L0 (4) Solero Generator Service Loaner US PG Catalog Number: 12740000USL UPN: H78712740000USL0

    FDA Enforcement
    Class II ·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·June 12, 2019