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
649–672 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Mar 07, 2025
ATMOS C 051 Thorax (317.0200.0)
K241799 · BTA
Atmos Medizintechnik GmbH & Co. KG
General & Plastic Surgery · 259d
Cleared Mar 06, 2025
Sterile Water USP and Sterile 0.9% Normal Saline USP
K243001 · FRO
Laboratorios Biogalenic S.A. DE C.V.
General & Plastic Surgery · 161d
Cleared Mar 06, 2025
XCELLARISPRO TWIST microneedling device
K241790 · QAI
Dermaroller GmbH
General & Plastic Surgery · 258d
Cleared Mar 05, 2025
NovoSorb® MTX
K242149 · QSZ
Polynovo Biomaterials Pty, Ltd.
General & Plastic Surgery · 225d
Cleared Mar 03, 2025
Q Switched Nd:YAG Laser machine (QNHF-01)
K242943 · GEX
Beijing Nubway S&T Co., Ltd.
General & Plastic Surgery · 159d
Cleared Mar 03, 2025
EnergyLounger (TY-01)
K241947 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 243d
Cleared Feb 28, 2025
da Vinci SP Advanced Access Port Kit (432701)
K243582 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 100d
Cleared Feb 28, 2025
MagDI System (MAG-02, DS-01)
K243359 · SAH
Gt Metabolic Solutions, Inc.
General & Plastic Surgery · 122d
Cleared Feb 27, 2025
XOD Diathermia Radiofrequency Device
K242175 · PBX
Xod, Inc.
General & Plastic Surgery · 218d
Cleared Feb 26, 2025
DEKA LOTUS
K250281 · ONF
El.En S.P.A.
General & Plastic Surgery · 26d
Cleared Feb 26, 2025
Heel Incision Safety Lancet (SteriHeel 2)
K244036 · FMK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 58d
Cleared Feb 26, 2025
Disposable Blood Lancet (Soft Pro)
K244031 · QRK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 58d
Cleared Feb 26, 2025
Vasoview Hemopro 3 Power Supply
K243918 · GEI
Maquet Cardiovascular, LLC
General & Plastic Surgery · 68d
Cleared Feb 25, 2025
ECHELON LINEAR™ Stapler 30mm Stapler (GTX30)
K243276 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 132d
Cleared Feb 24, 2025
Ulthera® System
K243035 · OHV
Ulthera, Inc.
General & Plastic Surgery · 150d
Cleared Feb 21, 2025
LYMA Laser PRO
K243330 · OHS
Lyma Life , Ltd.
General & Plastic Surgery · 120d
Cleared Feb 20, 2025
Medical diode laser systems (CHARISMA, REGAL)
K234004 · GEX
Reveal Lasers , Ltd.
General & Plastic Surgery · 429d
Cleared Feb 19, 2025
OPTOVISION Endoscopic Light Source Unit
K243591 · OWN
Optosurgical, LLC
General & Plastic Surgery · 91d
Cleared Feb 19, 2025
Single Use CO2 Laser Fiber (HAF005001)
K243588 · GEX
Quanta System Spa
General & Plastic Surgery · 91d
Cleared Feb 19, 2025
Phasix ST Umbilical Hernia Patch
K243241 · OWT
Davol, Inc., A Subsidiary of C.R....
General & Plastic Surgery · 132d
Cleared Feb 18, 2025
RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port
K243576 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 91d
Cleared Feb 14, 2025
CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F,...
K242593 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 168d
Cleared Feb 14, 2025
WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
K241643 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 252d
Cleared Feb 14, 2025
Pastelle Pro
K241527 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 260d