FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: General & Plastic Surgery ×
18,256 results
1–24 of 18,256
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Jul 31, 2026
da Vinci Surgical System, Model IS5000
K261824 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 60d
Cleared Jul 31, 2026
LightStim for Wrinkles (1984)
K261482 · OHS
Led Intellectual Properties, LLC
General & Plastic Surgery · 87d
Cleared Jul 30, 2026
neXus Ultrasonic Surgical Aspirator System
K261448 · LFL
Misonix, LLC
General & Plastic Surgery · 90d
Cleared Jul 24, 2026
5 Wavelength LED Facemask (TN2508)
K260598 · OHS
iSMART Developments, Ltd.
General & Plastic Surgery · 150d
Cleared Jul 24, 2026
EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing...
K253541 · GCJ
Medical Impact
General & Plastic Surgery · 252d
Cleared Jul 22, 2026
Lancet
K262211 · QRL
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 22d
Cleared Jul 22, 2026
AlphaTriPart - Monopolar MIC Instruments
K261179 · GEI
Gimmi GmbH
General & Plastic Surgery · 103d
Cleared Jul 22, 2026
Anovo Surgical System (6Ne)
K260804 · SCV
Momentis Surgical , Ltd.
General & Plastic Surgery · 132d
Cleared Jul 21, 2026
Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)
K261775
Xuzhou Kernel Medical Equipment Co.,...
General & Plastic Surgery · 53d
Cleared Jul 21, 2026
Medical Thulium Fiber Laser Systems (UroFiber 150Q)
K261738 · GEX
Rhein Laser Technologies Co., Ltd.
General & Plastic Surgery · 55d
Not Cleared Jul 21, 2026
OTTAVA™ Robotic Surgical System
DEN250068 · NAY
Auris Health, Inc., part of Johnson &...
General & Plastic Surgery · 215d
Cleared Jul 20, 2026
ENDOSCOPE HOLDER (182214)
K261573 · QZB
Aktormed GmbH
General & Plastic Surgery · 69d
Cleared Jul 20, 2026
Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating...
K254231 · FZP
Taiwan Surgical Corporation
General & Plastic Surgery · 203d
Cleared Jul 17, 2026
Diode laser hair removal machine (QDTM-04)
K261693 · GEX
Beijing Nubway S&T Co., Ltd.
General & Plastic Surgery · 56d
Cleared Jul 17, 2026
CHZL Red Light Therapy Hair Growth Cap...
K261675 · OAP
Shenzhen Chuanghong Zhilian...
General & Plastic Surgery · 57d
Cleared Jul 17, 2026
LED LCD Monitor (OEV-271H)
K261614 · GCJ
Lg Electronics.Inc
General & Plastic Surgery · 63d
Cleared Jul 16, 2026
Skin Air Cooling System (QALF-01)
K261674 · GEX
Beijing Nubway S&T Co., Ltd.
General & Plastic Surgery · 56d
Cleared Jul 15, 2026
XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368,...
K261407 · OHS
Dongguan Miqiang Technology Co., Ltd.
General & Plastic Surgery · 77d
Cleared Jul 14, 2026
Universal Seal (5-12 mm)
K261249 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Jul 13, 2026
Volnewmer™
K253504 · GEI
Classys, Inc.
General & Plastic Surgery · 255d
Cleared Jul 10, 2026
Capenergy C Equipments RF C200 and C400 Drakarian
K253480 · PBX
Capenergy Medical S.L.
General & Plastic Surgery · 269d
Cleared Jul 09, 2026
Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable...
K261988 · NEW
Teleflex Medical, LLC
General & Plastic Surgery · 27d
Cleared Jul 06, 2026
Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)
K260122 · QRL
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 172d
Cleared Jul 02, 2026
Collagen Wound Powder
K260596 · KGN
Ventris Medical
General & Plastic Surgery · 128d