New

Product Code: New


Products Classified as New

5764Suture, Surgical, Absorbable, PolydioxanoneAbsorbable Polydioxanone Surgical Suture.

Total Product Life Cycle (TPLC) Devices

5764Suture, Surgical, Absorbable, PolydioxanoneAbsorbable Polydioxanone Surgical Suture.

FDA Consensus Standards

Suture, Surgical, Absorbable, Polydioxanone [38449]21 CFR §878.4840 🔎
Suture, Surgical, Absorbable, Polydioxanone [38450]21 CFR §878.4840 🔎
Suture, Surgical, Absorbable, Polydioxanone [38454]21 CFR §878.4840 🔎
Suture, Surgical, Absorbable, Polydioxanone [38451]21 CFR §878.4840 🔎

Pre-market Approvals for New

N18331PDS SUTURE (DYED)ETHICON, INC.

Pre-market Notifications for New

K210871PDO Max Suture With Dual NeedlePDO MAX, Inc.
K192423MINT Product FamilyHans Biomed Corporation
K192144STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceEthicon, Inc.
K191361DemeDIOX Barbed Absorbable Surgical SutureDemeTECH Corporation
K190264ViolaMEDITIME Co., Ltd
K190245PDS Barbed Suture, PDO MAXX ThreadsPDO MAX, Inc.
K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control DevicesEthicon, Inc.
K181582DemeTECH DemeDIOX Absorbable Surgical SutureDemetech Corporation
K172602MiracuFeeltech Co., Ltd.
K162366Omega VLOV WORLD CO., LTD
K161737RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX UndyedMYCO MEDICAL
K160761DW-1CDONGWON MEDICAL CO., LTD.
K160705Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,Y. JACOBS MEDICAL, INC
K150670STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, INC.
K150553FilblocASSUT EUROPE

Global Unique Device Identification Database

20386120007278Suture, Surgical, Absorbable, Polydioxanone
20386120007261Suture, Surgical, Absorbable, Polydioxanone
20386120007254Suture, Surgical, Absorbable, Polydioxanone
20386120007247Suture, Surgical, Absorbable, Polydioxanone
20386120007230Suture, Surgical, Absorbable, Polydioxanone
20386120007223Suture, Surgical, Absorbable, Polydioxanone
20386120005885Suture, Surgical, Absorbable, Polydioxanone
20386120005830Suture, Surgical, Absorbable, Polydioxanone
20386120005823Suture, Surgical, Absorbable, Polydioxanone
20814639023842Suture, Surgical, Absorbable, Polydioxanone
20814639023835Suture, Surgical, Absorbable, Polydioxanone
20814639023774Suture, Surgical, Absorbable, Polydioxanone
20814639022715Suture, Surgical, Absorbable, Polydioxanone
20814639022708Suture, Surgical, Absorbable, Polydioxanone
20814639022692Suture, Surgical, Absorbable, Polydioxanone

Maude Adverse Events

SFX SPI PDS+ UNI VIO 12IN 2-0 S/A CT-1ETHICON INC.2020-03-31
SFX SPI PDS+ UNI VIO 12IN 2-0 S/A CT-1ETHICON INC.2020-03-31
SFX SPI PDS+ UNI VIO 12IN 2-0 S/A CT-1ETHICON INC.2020-03-31
PDSII VIO 27IN 4-0 S/A RB-1ETHICON INC.2020-03-31
PDSII VIO 27IN 2-0 S/A FS-1ETHICON INC.2020-03-31
PDSII VIO 27IN 3-0 S/A FS-1ETHICON INC.2020-03-31
SFX SYM PDS+ UNI VIO 18IN 1 S/A CTETHICON INC.2020-03-31
PDS CORD VIO 75CM 1.5MM SGLE ARMED V-40ETHICON INC.2020-03-30
PDSPLUS VIO 8X45 M2 SHB CRETHICON INC.2020-03-30
PDSII VIO 27IN 2-0 S/A SHETHICON INC.2020-03-30
PDSII VIO 36IN USP4-0ETHICON INC.2020-03-30
PDSII VIO 27IN 4-0 S/A BBETHICON INC.2020-03-30
SFX SYM PDS+ UNI VIO 18IN 1 S/A CTXBETHICON INC.2020-03-27
SFX SYM PDS+ UNI VIO 18IN 1 S/A CTXBETHICON INC.2020-03-27
STFX SYM PDS+ UNI VIO 24IN 1 S/A CTXETHICON INC.2020-03-27
PDSII VIO 27IN USP5-0ETHICON INC.2020-03-26
PDSII VIO 18IN USP4-0ETHICON INC.2020-03-26
PDS II CTX 2-0ETHICON, LLC2020-03-26
PDSII VIO 36IN 0 S/A CTB-1ETHICON INC.2020-03-25
PDS II VIO 150CM M3ETHICON INC.2020-03-25
PDS II VIO 150CM M3ETHICON INC.2020-03-25
PDS II VIO 150CM M3ETHICON INC.2020-03-25
PDS II VIO 150CM M3ETHICON INC.2020-03-25
PDS II VIO 150CM M3ETHICON INC.2020-03-25
ORTHOCORD VIOLET W/MO7 TAPRNDL * PK/12MEDOS INTERNATIONAL SàRL2020-03-25
SFX SYM PDS+ UNI VIO 18IN 1 S/A CTB-1ETHICON INC.2020-03-25
PDSII VIO 27IN 3-0 S/A FS-1ETHICON INC.2020-03-25
PDS PLUS VL LOOP 60ETHICON INC.2020-03-25
SFX SPI PDS+ UNI VIO 6IN 3-0 S/A SHETHICON INC.2020-03-24
PDSII VIO 27IN 3-0 S/A CP-2ETHICON INC.2020-03-24
PDSII VIO 27IN 3-0 S/A CP-2ETHICON INC.2020-03-24
PDSII VIO 27IN 3-0 S/A CP-2ETHICON INC.2020-03-24
PDSII VIO 60IN 0 S/A CTXB LPETHICON INC.2020-03-20
SFX SYM PDS+ UNI VIO 18IN 0 S/A CTETHICON INC.2020-03-19
SFX SPI PDS+ UNI VIO 12IN 2-0 S/A CT-1ETHICON INC.2020-03-19
PDS PLUS SUTURE 30"(75CM) 6-0 VIOETHICON INC.2020-03-19
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCTETHICON INC.2020-03-19
MONOPLUS VIOLET 4/0 (1.5) 45CM DS19 (M)B. BRAUN SURGICAL, S.A.2020-03-19
MONOPLUS VIOLET 1 (4) 90CM HR48 (M)B. BRAUN SURGICAL, S.A.2020-03-19
STFX SYM PDS+ UNI VIO 24IN 1 S/A CTXBETHICON INC.2020-03-19
PDSII VIO 27IN USP0ETHICON INC.2020-03-18
PDSII VIO 27IN USP0ETHICON INC.2020-03-18
PDSII VIO 27IN USP0ETHICON INC.2020-03-18
SFX SYM PDS+ UNI VIO 18IN 1 S/A CT-1ETHICON INC.2020-03-18
SFX SYM PDS+ UNI VIO 18IN 1 S/A CT-1ETHICON INC.2020-03-18
SFX SYM PDS+ UNI VIO 18IN 1 S/A CT-1ETHICON INC.2020-03-18
SFX SYM PDS+ UNI VIO 18IN 1 S/A CT-1ETHICON INC.2020-03-18
PDSII VIO 27IN 3-0 S/A SHETHICON INC.2020-03-17
PDSII VIO 36IN 1 S/A CTXBETHICON INC.2020-03-17
PDS+ VIO 27IN 2-0 S/A CT-1ETHICON INC.2020-03-17
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