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
73–96 of 18,256
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared May 28, 2026
Trexon™ Monofilament Synthetic Absorbable Suture
K253530 · GAM
Medtronic
General & Plastic Surgery · 196d
Cleared May 27, 2026
RENASYS EDGE (66803126)
K260646 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 89d
Cleared May 26, 2026
4K NIR/ICG Imaging System
K260318 · GCJ
Zhejiang Healnoc Technology Co., Ltd.
General & Plastic Surgery · 116d
Cleared May 26, 2026
VIVA combo RF System
K252833 · GEI
Starmed Co., Ltd.
General & Plastic Surgery · 263d
Cleared May 24, 2026
MediBot Needle Driver Uno
K260183 · GCJ
Parallel Robotics, LLC
General & Plastic Surgery · 123d
Cleared May 22, 2026
da Vinci Firefly Imaging System
K260695 · NAY
Intuitive Surgical
General & Plastic Surgery · 80d
Cleared May 22, 2026
Spectrum-2
K254129 · MUD
Neko Health AB
General & Plastic Surgery · 151d
Cleared May 21, 2026
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU,...
K261325 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 29d
Cleared May 21, 2026
Nisus NPWT Canister 500-mL (CPC-500)
K261291 · OMP
Cork Medical
General & Plastic Surgery · 31d
Cleared May 21, 2026
Ulthera® System
K260618 · OHV
Ulthera, Inc.
General & Plastic Surgery · 85d
Cleared May 21, 2026
ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015,...
K253956 · FTL
Sofradim Production
General & Plastic Surgery · 162d
Cleared May 21, 2026
Boston 2910 (Boston 2910)
K253245 · GEX
Boston Aesthetics, Inc.
General & Plastic Surgery · 234d
Not Cleared May 21, 2026
DeepView AI® System
DEN250028 · SHY
Spectralmd, Inc.
General & Plastic Surgery · 328d
Cleared May 20, 2026
IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG,...
K260594 · OHT
Shenzhen Xiazhifeng Electronic Co., Ltd.
General & Plastic Surgery · 86d
Cleared May 20, 2026
LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)
K253134 · GEI
Lagis Enterprise Co., Ltd.
General & Plastic Surgery · 237d
Cleared May 19, 2026
Laport
K252985 · GCJ
Sejong Medical Co., Ltd.
General & Plastic Surgery · 243d
Cleared May 18, 2026
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices
K252047 · NEW
Ethicon, Inc.
General & Plastic Surgery · 322d
Cleared May 14, 2026
MatriDerm
K261224 · KGN
Medskin Solutions Dr. Suwelack AG
General & Plastic Surgery · 30d
Cleared May 14, 2026
Suction Pump (SU-90)
K260892 · BTA
Shenzhen HugeMed Medical Technical...
General & Plastic Surgery · 57d
Cleared May 13, 2026
StatSeal Disc
K254073 · FRO
Merit Medical Systems, Inc.
General & Plastic Surgery · 146d
Cleared May 13, 2026
SURGIMAGE SIM 1000H Fluorescence Imaging Platform
K253181 · IZI
Surgimage Corporation
General & Plastic Surgery · 229d
Cleared May 13, 2026
Automatic Micro Needle System (CODE-X)
K252591 · QAI
Woorhi Mechatronics Co., Ltd.
General & Plastic Surgery · 271d
Cleared May 12, 2026
Promisemed VeriEcto Automatic Biopsy Needles
K261196 · KNW
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 29d
Cleared May 12, 2026
myLEDmask 2 (MJ-144)
K260415 · OHS
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 92d