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
313–336 of 18,256
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Oct 31, 2025
Kii Structural Balloon Access System
K252442 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 88d
Cleared Oct 31, 2025
Diode Laser Hair Removal Machine (GLD01)
K252427 · GEX
Sanhe Meditech Co., Ltd.
General & Plastic Surgery · 91d
Cleared Oct 31, 2025
Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)
K252412 · GEI
Applied Medical Resources Corporation
General & Plastic Surgery · 91d
Cleared Oct 30, 2025
ellacor System with Micro-Coring Technology
K252752 · QAI
Cytrellis Biosystems, Inc.
General & Plastic Surgery · 62d
Cleared Oct 30, 2025
Moses™ 200 D/F/L Laser Fiber (M0068130100)
K252529 · GEX
Boston Scientific Corporation
General & Plastic Surgery · 80d
Cleared Oct 30, 2025
Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
K252414 · OAP
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 90d
Cleared Oct 29, 2025
SER Pen Carain MicroSystem (MP1209SP)
K253153 · QAI
Su-Ko Technologies, LLC
General & Plastic Surgery · 33d
Cleared Oct 29, 2025
3D Laparoscope
K252697 · GCJ
Guangdong Optomedic Technologies, Inc.
General & Plastic Surgery · 63d
Cleared Oct 28, 2025
PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch
K250275 · GEI
Baylis Medical Technologies, Inc.
General & Plastic Surgery · 270d
Cleared Oct 27, 2025
VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)
K252053 · OHS
Touchbeauty Beauty & Health...
General & Plastic Surgery · 118d
Cleared Oct 27, 2025
Patriot Duo
K251824 · GEX
Patriot Laser, LLC
General & Plastic Surgery · 136d
Cleared Oct 24, 2025
Parietene™ Flat Sheet Mesh
K253125 · FTL
Medtronic - Sofradim Production
General & Plastic Surgery · 29d
Cleared Oct 23, 2025
MultiPulse TFL
K253100 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 29d
Cleared Oct 23, 2025
1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)
K252732 · GEX
Zhengzhou PZ Laser Slim Technology...
General & Plastic Surgery · 56d
Cleared Oct 23, 2025
Picosecond Laser Device (PF131-BI)
K252345 · GEX
Risu Medical Technology Co., Ltd.
General & Plastic Surgery · 87d
Cleared Oct 22, 2025
Hair Growth Laser Cap
K252325 · OAP
Cosmo Far East Technology Limited
General & Plastic Surgery · 89d
Cleared Oct 21, 2025
ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)
K250126 · GEI
Livsmed, Inc.
General & Plastic Surgery · 277d
Cleared Oct 20, 2025
VereSee Optical Veres Needle and Endoscopic Camera
K252640 · GCJ
Freyja Healthcare, LLC
General & Plastic Surgery · 60d
Cleared Oct 20, 2025
Q-Switched Nd: YAG Laser machine (LFS-C13U)
K252319 · GEX
Sanhe?Lefis?Electronics?Co., Ltd.
General & Plastic Surgery · 87d
Cleared Oct 20, 2025
AVAVA™ Skin Treatment System
K252155 · ONG
Avava, Inc.
General & Plastic Surgery · 103d
Cleared Oct 20, 2025
Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)
K251414 · NEW
Feeltech Co., Ltd.
General & Plastic Surgery · 166d
Cleared Oct 17, 2025
MEGELIN LED Light Therapy Mask (JML1, JML1+JML2)
K252264 · OHS
Shenzhen Zhenxing Ruitong Technology...
General & Plastic Surgery · 88d
Cleared Oct 16, 2025
TargetCool™ (RM-DT02W)
K253114 · GEH
Recensmedical, Inc.
General & Plastic Surgery · 22d
Cleared Oct 16, 2025
ProZip Knotless Implant
K253024 · GAT
Riverpoint Medical
General & Plastic Surgery · 27d