BEUDAMED
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    MEDICAL MONOFILAMENT MANUFACTURING

    FDA registration
    MEDICAL MONOFILAMENT MANUFACTURING·1 product·🇺🇸 United States

    Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model Number: AM140

    FDA Enforcement
    Class III ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022

    Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model Number: AM140

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code GAQ·May 25, 2022

    AZUR HYDROPACK 18

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC·Product code KRD·May 1, 2024

    ACCU-PASS STR SHUTTLE 45 DEG RGHT CRVE

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code LXH·August 26, 2025

    HYDROFILL HELICAL

    FDA Adverse Event
    Malfunction ·MICROVENTION INC.·Product code KRD·September 12, 2024

    GORE-TEX® STRETCH VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DSY·June 17, 2024

    HYDROFILL HELICAL

    FDA Adverse Event
    Malfunction ·MICROVENTION INC.·Product code KRD·September 13, 2024

    AZUR-35 DETACHABLE HYDRO

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC.·Product code KRD·December 5, 2023

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·August 17, 2017

    BIODESIGN TENSION FREE URETHRAL SLING

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code FTM·August 9, 2016

    AZUR 18 HYDROCOIL DETACHABLE

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC·Product code KRD·September 20, 2023

    PHASIX MESH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC. -1213643·Product code OOD·March 25, 2025

    PHASIX MESH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC. -1213643·Product code OOD·May 9, 2024

    PHASIX ST MESH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code OWT·September 4, 2018

    Product is an EO Sterile, Polydioxanone Violet monofilament synthetic absorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is sealed inside an inner foil pouch with an outside tyvek pouch. The outer tyvek pouch has the defective seal. No suture is exposed or visible through the foil wrap which must be torn to have access to the suture and needle. Product is boxed (12 to a box) and shrink wrapped. Product is labeled STERILE. Box Label includes: '3/0 (2.0 metric) MONO-DOX Violet Monofilament Polydioxanone Suture USP M398A CP-B-M398A-04 Rx Only NFS-2 19 mm 3/8 CUTTING Manufactured by: CP Medical Portland, OR USA 30' (75 cm) One Dozen Sterile Synthetic Absorbable Suture '. Packet Label includes: '3/0 (2.0 metric) 398 NFS-2 19mm 3/8 CUTTING 30' (75cm) POLYDIOXANONE Violet (PDO) Monofilament Synthetic Absorbable Suture STERILE EO Manufacturer: CP Medical Portland, OR USA' . Product is also distributed under three private labels, Webster Veterinary, Butler, and Phoenix Pharmaceutical, Inc. Webster Veterinary Box Label includes: '3/0 (2.0 metric) WEBMAX Violet Monofilament Polydioxanone Suture Distributed by: WEBSTER VETERINARY 07-836-4288(M398A) 26-BM398A-01 Vet Use Only CUTTING NFS-2 30' (75 cm) 3/8 19mm'. Webster Veterinary Packet Label includes: '3/0 (2.0 metric) 07-836-4288(M398A) WEBMAX Violet Monofilament Polydioxanone Absorbable Sterile Suture 30' (75cm) Vet Use Only Distributed by: Webster Veterinary Supply, Inc. CUTTING NFS-2 3/8 19mm 26-SM398A-01'. Butler Box label includes: 'Butler 3/0 (2.0 metric) MONOSORB Violet Monofilament Polydioxanone Suture 029254 Vet Use Only NFS-2 CUTTING 30' (75 cm) 3/8 19mm 01-BM398A-02 SUTUREVET'. Butler Packet Label includes: '3/0 (2.0 metric) NFS-2 19mm 3/8 CUTTING 30' (75cm) 029254 MONOSORB Violet Monofilament Prolydioxanone Synthetic Absorbable Suture STERILE EO Distributed Exclusively by: Butler Animal Health Supply'. Phoenix Pharmaceutical Box label includes: '3/0 (2.0 metric) 0398 Poly-Dox Sutures VIOLET MONOFILAMENT (Polydioxanone) Suture Sterile Synthetic Absorbable Suture 30' (75cm) Vet Use Only Cutting PFS-2 3/8 19mm Distributed By: PHOENIX PHARMACEUTICAL, INC.'. Phoenix Pharmaceutical Packet label includes: '3/0 (2.0 metric) 0398 Poly-Dox Sutures VIOLET MONOFILAMENT (Polydioxanone) Suture 30' (75cm) Sterile, Synthetic Absorbable Suture Veterinary Use Only Cutting PFS-2 3/8 19mm Distributed By: PHOENIX PHARMACEUTICAL, INC.'.

    FDA Recall
    Terminated ·C P Medical·Product code GAM·April 3, 2007

    BARD FLAT MESH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·April 8, 2016

    AZUR CX 35 DETACHABLE

    FDA Adverse Event
    Injury ·MICROVENTION, INC.·Product code KRD·August 15, 2023

    COSMOS-10-AV

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC.·Product code HCG·January 25, 2023

    AZUR

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC.·Product code KRD·April 11, 2026