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

Filters: General & Plastic Surgery ×
18,368 results
2161–2184 of 18,368
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Sep 17, 2021
RedEx
K211234 · GCJ
Advanced Surgical Concepts, Ltd.
General & Plastic Surgery · 147d
Cleared Sep 17, 2021
Uramix CuraWay Biopsy Needle
K203141 · KNW
Uramix, Inc.
General & Plastic Surgery · 332d
Cleared Sep 14, 2021
Viveve System, Viveve 2.0 System
K212678 · GEI
Viveve Medical, Inc.
General & Plastic Surgery · 21d
Cleared Sep 13, 2021
HandX
K212214 · GCJ
Human Xtensions , Ltd.
General & Plastic Surgery · 60d
Cleared Sep 09, 2021
Exofin Precision Pen
K212246 · MPN
Chemence Medical, Inc.
General & Plastic Surgery · 52d
Cleared Sep 07, 2021
CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal...
K211579 · GEI
Bolder Surgical, LLC
General & Plastic Surgery · 109d
Cleared Sep 07, 2021
PreferX Delivery System
K210997 · FMF
Md3, LLC
General & Plastic Surgery · 158d
Cleared Sep 03, 2021
AROMA GRAND
K211637 · GEX
Daeju Meditech Engineering Co., Ltd.
General & Plastic Surgery · 99d
Cleared Sep 01, 2021
Omeza Collagen Matrix
K211972 · FRO
Omeza, LLC
General & Plastic Surgery · 69d
Cleared Sep 01, 2021
IPL Hair Removal
K211174 · OHT
Shenzhen Qiaochengli Technology Co.,...
General & Plastic Surgery · 134d
Cleared Sep 01, 2021
Leonardo Mini Blue
K210951 · GEX
Ceramoptec GmbH
General & Plastic Surgery · 155d
Cleared Aug 30, 2021
Senhance Surgical System
K212054 · NAY
Asensus Surgical, Inc.
General & Plastic Surgery · 61d
Cleared Aug 27, 2021
XSTAT 30 Pouch
K210676 · PGZ
Revmedx, Inc.
General & Plastic Surgery · 175d
Cleared Aug 26, 2021
Heel Incision Safety Lancet
K210745 · FMK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 167d
Cleared Aug 25, 2021
CellFX System
K211444 · GEI
Pulse Biosciences, Inc.
General & Plastic Surgery · 107d
Cleared Aug 25, 2021
SCAR 3
K211362 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 114d
Cleared Aug 23, 2021
npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™
K201400 · QPX
Aatru Medical, LLC
General & Plastic Surgery · 452d
Cleared Aug 19, 2021
SurgiLattice scaffold
K202425 · OOD
Tepha, Inc.
General & Plastic Surgery · 359d
Cleared Aug 18, 2021
Cellvizio I.V.E. system with Confocal Miniprobes
K212322 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 23d
Cleared Aug 16, 2021
Disposable Monopolar Laparoscopic Shafts and Reusable Handles
K210569 · GEI
Dannik, LLC
General & Plastic Surgery · 171d
Cleared Aug 13, 2021
Pitch-Patchs
K211563 · FTL
Xiros, Ltd.
General & Plastic Surgery · 85d
Cleared Aug 13, 2021
Nisus Touch Negative Pressure Wound Therapy Pump
K203693 · OMP
Cork Medical Products, LLC
General & Plastic Surgery · 238d
Cleared Aug 12, 2021
Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices,...
K210946 · KNW
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 135d
Cleared Aug 06, 2021
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
K211784 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 58d