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
97–120 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2026
Roosin Collagen Dressing
K253974 · KGN
Roosin Medical Co., Ltd.
General & Plastic Surgery · 174d
Cleared Jun 02, 2026
Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
K253918 · GEI
F Care Systems USA, LLC
General & Plastic Surgery · 176d
Cleared Jun 02, 2026
MILAN System
K253803 · GEI
Lumenis Be, Ltd.
General & Plastic Surgery · 186d
Cleared Jun 02, 2026
Hemospray Endoscopic Hemostat (HEMO-[X])
K253302 · QAU
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 246d
Cleared Jun 02, 2026
Inno-Port Disposable Bladed Trocar
K252532 · GCJ
Taiwan Surgical Corporation
General & Plastic Surgery · 294d
Cleared May 29, 2026
ENTire IRE System
K261202 · GEI
Entire Medical , Ltd.
General & Plastic Surgery · 46d
Cleared May 29, 2026
LASEmaR 1500
K260489 · GEX
Eufoton S.R.L.
General & Plastic Surgery · 105d
Cleared May 28, 2026
780 nm SPY Portable Handheld Imaging (SPY-PHI) System
K261037 · IZI
Stryker Endoscopy
General & Plastic Surgery · 59d
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