Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

212 results for "Ethicon, Inc."
1–24 of 212
Search insights Median review: 86d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Jun 25, 2026
Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture
K253394 · GAM
Ethicon, Inc.
General & Plastic Surgery · 268d
Cleared May 18, 2026
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices
K252047 · NEW
Ethicon, Inc.
General & Plastic Surgery · 322d
Cleared Mar 27, 2026
STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device...
K253572 · GAW
Ethicon, Inc.
General & Plastic Surgery · 130d
Cleared Feb 06, 2026
MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile...
K253852 · GAM
Ethicon, Inc.
General & Plastic Surgery · 66d
Cleared Dec 22, 2025
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device
K252743 · GAM
Ethicon, Inc.
General & Plastic Surgery · 116d
Cleared Nov 12, 2025
PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical...
K243897 · NEW
Ethicon, Inc.
General & Plastic Surgery · 328d
Cleared Nov 15, 2022
STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device
K221744 · GAM
Ethicon, Inc.
General & Plastic Surgery · 152d
Cleared Feb 22, 2022
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical...
K212380 · NEW
Ethicon, Inc.
General & Plastic Surgery · 204d
Cleared Dec 07, 2021
DERMABOND PRINEO Skin Closure System
K213512 · OMD
Ethicon, Inc.
General & Plastic Surgery · 35d
Cleared Dec 21, 2020
Monocryl Plus Antibacterial Suture
K201996 · GAM
Ethicon, Inc.
General & Plastic Surgery · 154d
Cleared Sep 17, 2020
GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE...
K201686 · OTN
Ethicon, Inc.
Gastroenterology & Urology · 87d
Cleared Aug 06, 2020
VICRYL Mesh
K201143 · FTL
Ethicon, Inc.
General & Plastic Surgery · 99d
Cleared Mar 25, 2020
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
K192144 · NEW
Ethicon, Inc.
General & Plastic Surgery · 230d
Cleared Dec 18, 2019
STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device
K192580 · GAM
Ethicon, Inc.
General & Plastic Surgery · 90d
Cleared Oct 22, 2019
VICRYL Mesh
K191373 · FTL
Ethicon, Inc.
General & Plastic Surgery · 152d
Cleared Jun 27, 2019
VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II...
K183183 · GAM
Ethicon, Inc.
General & Plastic Surgery · 220d
Cleared Jan 10, 2019
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX...
K182873 · NEW
Ethicon, Inc.
General & Plastic Surgery · 90d
Cleared Sep 28, 2018
Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture
K181652 · GAM
Ethicon, Inc.
General & Plastic Surgery · 98d
Cleared Aug 10, 2018
GYNECARE TVT Abbrevo Continence System
K181151 · PWJ
Ethicon, Inc.
General & Plastic Surgery · 101d
Cleared Aug 02, 2018
Temporary Cardiac Pacing Wire
K173923 · LDF
Ethicon, Inc.
Cardiovascular · 219d
Cleared Jul 26, 2018
PROLENE (Polypropylene) 3D Patch
K181268 · FTL
Ethicon, Inc.
General & Plastic Surgery · 73d
Cleared Jul 06, 2018
GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide,...
K173019 · PWJ
Ethicon, Inc.
Gastroenterology & Urology · 281d
Cleared Jul 02, 2018
ULTRAPRO Mesh and ULTRAPRO ADVANCED
K180910 · FTL
Ethicon, Inc.
General & Plastic Surgery · 87d
Cleared Jun 28, 2018
PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE...
K180829 · FTL
Ethicon, Inc.
General & Plastic Surgery · 90d