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
505–528 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2025
AuroLase® System
K243701 · GEX
Nanospectra Biosciences, Inc.
General & Plastic Surgery · 215d
Cleared Jul 02, 2025
Boehringer Laboratories Liver Retractor
K243399 · GCJ
Boehringer Laboratories, LLC
General & Plastic Surgery · 244d
Cleared Jul 01, 2025
Endoscopic Camera System
K250204 · FET
Shenzhen Sophway Technology Co., Ltd.
General & Plastic Surgery · 158d
Cleared Jul 01, 2025
droplet® personal lancets
K250016 · QRK
Htl-Strefa S.A
General & Plastic Surgery · 179d
Cleared Jun 30, 2025
Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07,...
K251000 · OHT
Shenzhen Chuangtong Yigou Technology...
General & Plastic Surgery · 90d
Cleared Jun 27, 2025
Diode laser device (RF3120-BI)
K251329 · GEX
Risu Medical Technology Co., Ltd.
General & Plastic Surgery · 58d
Cleared Jun 27, 2025
Maestro System (REF100)
K250984 · QZB
Moon Surgical
General & Plastic Surgery · 88d
Cleared Jun 27, 2025
Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)
K243187 · OMP
Cork Medical
General & Plastic Surgery · 270d
Cleared Jun 26, 2025
safety lancet
K251694 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 24d
Cleared Jun 26, 2025
Optimas MAX System
K251632 · GEX
Inmode , Ltd.
General & Plastic Surgery · 29d
Cleared Jun 26, 2025
Lap.Ox™ Laparoscopic Tissue Oximeter
K250519 · MUD
Vioptix, Inc.
General & Plastic Surgery · 125d
Cleared Jun 25, 2025
CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)
K250966 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 86d
Cleared Jun 25, 2025
GeniPhys Collymer Self-Assembling Scaffold
K250329 · KGN
Geniphys, Inc.
General & Plastic Surgery · 140d
Cleared Jun 24, 2025
HyperSnap Surgical System (HSS)
K250268 · SFE
Hypervision Surgical
General & Plastic Surgery · 145d
Cleared Jun 23, 2025
OPXION Optical Skin Viewer (OPXSV1-01F)
K242924 · NQQ
Opxion Technology, Inc.
General & Plastic Surgery · 272d
Cleared Jun 20, 2025
NovoSorb BTM
K251567 · QSZ
Polynovo Biomaterials Pty, Ltd.
General & Plastic Surgery · 29d
Cleared Jun 20, 2025
Restrata Soft Tissue Reinforcement (STR)
K251224 · OXF
Acera Surgical, Inc.
General & Plastic Surgery · 60d
Cleared Jun 20, 2025
LED LIGHT MASK (A093)
K250880 · OHS
Foshan Guangyu Weilai Medical...
General & Plastic Surgery · 88d
Cleared Jun 20, 2025
LED Facial Mask
K243978 · OHS
Shenzhen Sunsred Technology Co.,Ltd
General & Plastic Surgery · 179d
Cleared Jun 20, 2025
HybridAPC probe
K243120 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 263d
Cleared Jun 20, 2025
CollOvine™ Wound Dressing
K242985 · KGN
Ovigenex, LLC
General & Plastic Surgery · 267d
Cleared Jun 19, 2025
Electrosurgical Pads
K251235 · GEI
Baisheng Medical Co., Ltd.
General & Plastic Surgery · 58d
Cleared Jun 18, 2025
SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10)
K242894 · LFL
Shanghai Saints Sages Surgical Co., Ltd.
General & Plastic Surgery · 268d
Cleared Jun 17, 2025
CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)
K251017 · OAP
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 76d