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
481–504 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Jul 22, 2025
Disposable Biopsy Needle
K244018 · KNW
Zhejiang Curaway Medical Technology...
General & Plastic Surgery · 207d
Cleared Jul 22, 2025
Granudacyn® Wound Irrigation Solution
K243415 · FRO
P.G.F. Industry Solutions GmbH
General & Plastic Surgery · 263d
Cleared Jul 17, 2025
Masimo O3 Regional Oximeter
K243324 · MUD
Masimo Corporation
General & Plastic Surgery · 267d
Cleared Jul 16, 2025
Marigen Wound Extra
K251845 · KGN
Kerecis Limited
General & Plastic Surgery · 30d
Cleared Jul 16, 2025
da Vinci Surgical System (IS5000)
K251202 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Jul 15, 2025
Kerecis SurgiBind (50241)
K251844 · OXH
Kerecis Limited
General & Plastic Surgery · 29d
Cleared Jul 14, 2025
Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD,...
K251173 · OHT
Shenzhen Fansizhe Science And...
General & Plastic Surgery · 89d
Cleared Jul 14, 2025
Leonardo Duster
K250504 · GEX
Ceramoptec GmbH
General & Plastic Surgery · 144d
Cleared Jul 11, 2025
AEON™ Endoscopic Powered Stapler
K251482 · GAG
Lexington Medical, Inc.
General & Plastic Surgery · 58d
Cleared Jul 11, 2025
AviClear Laser System
K251149 · GEX
Cutera, Inc.
General & Plastic Surgery · 88d
Cleared Jul 11, 2025
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP,...
K250942 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 105d
Cleared Jul 11, 2025
Disposable Trocars
K250820 · GCJ
Sinolinks Medical Innovation, Inc.
General & Plastic Surgery · 115d
Cleared Jul 11, 2025
KALA Therapy Wand (Model: KALA-03)
K250761 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 120d
Cleared Jul 11, 2025
Disposable Biopsy Needle
K243296 · KNW
Carbon (Shenzhen) Medical Device Co.,...
General & Plastic Surgery · 266d
Cleared Jul 10, 2025
Marquee™ Disposable Core Biopsy Instrument and Instrument Kit
K250032 · KNW
Bard Peripheral Vascular, Inc.
General & Plastic Surgery · 184d
Cleared Jul 08, 2025
Anovo Surgical System (Model 6Ne)
K251761 · QNM
Momentis Surgical , Ltd.
General & Plastic Surgery · 29d
Cleared Jul 08, 2025
DENSITY
K250065 · GEI
Jeisys Medical Incorporated
General & Plastic Surgery · 179d
Cleared Jul 03, 2025
Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips
K251054 · FZP
Teleflex Medical
General & Plastic Surgery · 90d
Cleared Jul 03, 2025
Pastelle
K250165 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 163d
Cleared Jul 03, 2025
IPL Treatment Device (MDSQMC-01)
K243123 · ONF
Medusa (Guangxi)Medical Devices Co.,...
General & Plastic Surgery · 276d
Cleared Jul 02, 2025
8 mm Assist Cannula
K251490 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 49d
Cleared Jul 02, 2025
SurgiLight 1470 Diode Laser System (Model:Halo)
K251049 · GEX
Micro-Energy Medical Technology Co.,...
General & Plastic Surgery · 90d
Cleared Jul 02, 2025
Fiber Laser Treatment Systems (HS-232,HS-233)
K251031 · ONG
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 90d
Cleared Jul 02, 2025
CS-Pro MED
K250779 · PZL
Curative Sound Therapeutics
General & Plastic Surgery · 110d