OTN

Product Code: OTN


Products Classified as OTN

2177Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorSurgical Mesh.

Total Product Life Cycle (TPLC) Devices

2177Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorSurgical Mesh.

Pre-market Notifications for OTN

K211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemCaldera Medical, Inc.
K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation
K210087Athena Surgical RMUS SystemAthena Surgical, LLC
K201686GYNECARE TVT™ System, GYNECARE TVT™ With Abdominal Guides System, GYNECARE TVT™ Introducer And Catheter Guide, GYNECARE TVT EXACT™ Continence System And Trocar, GYNECARE TVT™ Obturator System And Passers And Winged Guide, GYNECARE TVT ABBREVO™ ContinEthicon Inc.
K183134ArcTV Transvaginal Sling SystemUroCure LLC
K162201Desara TV, Desara Blue TVCALDERA MEDICAL, INC.
K140843DESARA BLUE OV, DESARA BLUE SSCALDERA MEDICAL
K132655RETROARC RETROPUBIC SLING SYSTEMAMERICAN MEDICAL SYSTEMS, INC.
K132069DESARA MESH, DESARA BLUECALDERA MEDICAL, INC.
K132054GYNECARE TVT EXACT CONTINENCE SYSTEMETHICON, INC.
K131229SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMSAMERICAN MEDICAL SYSTEMS
K121928DESARA SLCALDERA MEDICAL, INC.
K121754BLUE SUI SLINGBOSTON SCIENTIFIC CORP.
K112609DESARA MESHCALDERA MEDICAL, INC.
K111219GMD UNIVERSAL URINARY INCONTINENCE SLINGGENERIC MEDICAL DEVICE, INC.

Global Unique Device Identification Database

00801741016240mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
00801741016233mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
00801741016226mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
00801741016219mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
00801741016202mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
00801741016196mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
00801741016189mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
00801741016172mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator
00814723020494Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
00814723020487Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
00814723020463Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
00814723020449Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
00814723020425Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
00814723020401Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
00814723020371Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Maude Adverse Events

ADVANTAGE FIT SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-31
TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PRODETHICON INC.2020-03-31
ADVANTAGE FIT SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-30
TVT EXACT RETROPUBIC SYSTEMETHICON INC.2020-03-27
GYNECARE TVT-ABBREVO MINI LCMETHICON INC.2020-03-27
ADVANTAGE FIT SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-27
GYNECARE TVT OBTURATOR W LASRETHICON INC.2020-03-27
TVT EXACT RETROPUBIC SYSTEMETHICON INC.2020-03-27
TVT EXACT RETROPUBIC SYSTEMETHICON INC.2020-03-27
GYNECARE TVT OBTURATORETHICON INC.2020-03-26
OBTRYX SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-25
ALIGN URETHRAL SUPPORT SYSTEM RETROPUBICC.R. BARD, INC. (COVINGTON) -10182332020-03-25
ALIGN URETHRAL SUPPORT SYSTEMC.R. BARD, INC. (COVINGTON) -10182332020-03-24
LYNX SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-23
GYNECARE TVT OBTURATORETHICON INC.2020-03-23
TVT DEVICE W/BLUE MESHETHICON INC.2020-03-23
OBTRYX SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-23
ALIGN TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM WITH HALO NEEDLEC.R. BARD, INC. (COVINGTON) -10182332020-03-23
OBTRYX SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-23
OBTRYX II SYSTEM - HALOBOSTON SCIENTIFIC CORPORATION2020-03-20
TVT DEVICE LCMETHICON INC.2020-03-20
TENSION FREE VAGINAL TAPE UNKNOWN PRODUCTETHICON INC.2020-03-20
LYNX SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
ADVANTAGE FIT SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
LYNX SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
OBTRYX SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
PREFYX PPS SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
ADVANTAGE FIT SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
ADVANTAGE SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
ADVANTAGE SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
OBTRYX II SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
ALIGN (R) URETHRAL SUPPORT SYSTEMC.R. BARD, INC. (COVINGTON) -10182332020-03-19
GYNECARE TVT OBTURATORETHICON INC.2020-03-19
OBTRYX SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
PREFYX PPS SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
OBTRYX SYSTEM - CURVEDBOSTON SCIENTIFIC CORPORATION2020-03-19
ADVANTAGE FIT SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
OBTRYX SYSTEM - HALOBOSTON SCIENTIFIC CORPORATION2020-03-19
OBTRYX SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
PREFYX PPS SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
OBTRYX SYSTEM - HALOBOSTON SCIENTIFIC CORPORATION2020-03-19
PREFYX PPS SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
OBTRYX SYSTEM - HALOBOSTON SCIENTIFIC CORPORATION2020-03-19
ADVANTAGE FIT SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
OBTRYX SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
OBTRYX SYSTEM - HALOBOSTON SCIENTIFIC CORPORATION2020-03-19
ADVANTAGE SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
ADVANTAGE SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
LYNX SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19
ADVANTAGE FIT SYSTEMBOSTON SCIENTIFIC CORPORATION2020-03-19

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