FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General & Plastic Surgery ×
18,288 results
2089–2112 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
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
Cleared Aug 05, 2021
R2 Dermabrasion Tip (for Dermal Cooling System)
K203006 · QPZ
R2 Technologies, Inc.
General & Plastic Surgery · 308d
Cleared Aug 04, 2021
Ultrasonic Bipolar Generator USG-410 with accessories
K211838 · LFL
Olympus Medical Systems Corporation
General & Plastic Surgery · 51d
Cleared Aug 03, 2021
Venclose digiRF Generator with Maven Catheter, Venclose Maven System,...
K211806 · GEI
Venclose, Inc.
General & Plastic Surgery · 53d
Cleared Jul 30, 2021
UltraLase Flexible CO2 Laser Waveguide
K211761 · GEX
W & R Investments, LLC Dba Laser...
General & Plastic Surgery · 52d
Cleared Jul 30, 2021
Powersculp laser lipolysis system
K211402 · PKT
Lotuxs Medtech (Suzhou) Co., Ltd.
General & Plastic Surgery · 85d
Cleared Jul 30, 2021
Lab Bag with Fabric Pouch
K210248 · GCJ
Advanced Medical Design Co., Ltd.
General & Plastic Surgery · 182d
Cleared Jul 30, 2021
Sectum
K202780 · PBX
Neauvia North America
General & Plastic Surgery · 311d
Cleared Jul 28, 2021
Braun Silk.expert Mini
K211994 · OHT
Cyden Limited
General & Plastic Surgery · 30d