Ethicon, Inc. - FDA 510(k) Cleared Devices
Recent clearances: STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices, STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device, MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
204
Total
197
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ethicon, Inc. General & Plastic Surgery ✕
154 devices
Cleared
May 18, 2026
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices
General & Plastic Surgery
322d
Cleared
Mar 27, 2026
STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device...
General & Plastic Surgery
130d
Cleared
Feb 06, 2026
MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile...
General & Plastic Surgery
66d
Cleared
Dec 22, 2025
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device
General & Plastic Surgery
116d
Cleared
Nov 12, 2025
PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical...
General & Plastic Surgery
328d
Cleared
Nov 15, 2022
STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device
General & Plastic Surgery
152d
Cleared
Feb 22, 2022
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical...
General & Plastic Surgery
204d
Cleared
Dec 07, 2021
DERMABOND PRINEO Skin Closure System
General & Plastic Surgery
35d
Cleared
Dec 21, 2020
Monocryl Plus Antibacterial Suture
General & Plastic Surgery
154d
Cleared
Aug 06, 2020
VICRYL Mesh
General & Plastic Surgery
99d
Cleared
Mar 25, 2020
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
General & Plastic Surgery
230d
Cleared
Dec 18, 2019
STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device
General & Plastic Surgery
90d
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