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
2017–2040 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Nov 23, 2021
da Vinci SP Firefly Imaging System
K212101 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 140d
Cleared Nov 23, 2021
Virtue RF
K211562 · GEI
ShenB Co., Ltd.
General & Plastic Surgery · 187d
Cleared Nov 22, 2021
VS3 Iridium Sytem
K210265 · OWN
Visionsense, Ltd.
General & Plastic Surgery · 294d
Cleared Nov 19, 2021
Arthrex Vortex Threaded Bone Marrow Recovery Needle
K213213 · KNW
Arthrex, Inc.
General & Plastic Surgery · 51d
Cleared Nov 19, 2021
Leaf Smooth
K212697 · OHT
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Nov 19, 2021
Finebeam
K202288 · GEX
Snj Co., Ltd.
General & Plastic Surgery · 464d
Cleared Nov 18, 2021
IPL Hair Removal, Model: OBT-02
K213041 · OHT
Glan Electronics Co., Ltd.
General & Plastic Surgery · 57d
Cleared Nov 18, 2021
Dermalux Flex MD
K212275 · OHS
Aesthetic Technology, Ltd.
General & Plastic Surgery · 121d
Cleared Nov 15, 2021
KARL STORZ ICG Imaging System
K212695 · OWN
Karl Storz Endoscopy America
General & Plastic Surgery · 82d
Cleared Nov 15, 2021
Darwin
K212607 · GEX
Luvo Medical Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Nov 15, 2021
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
K212301 · LFL
Covidien, LLC
General & Plastic Surgery · 115d
Cleared Nov 15, 2021
SofWave System
K211483 · OHV
Sofwave Medical, Ltd.
General & Plastic Surgery · 187d
Cleared Nov 10, 2021
Diode laser therapy system
K212978 · GEX
Beijing Unt Technology Co., Ltd.
General & Plastic Surgery · 54d
Cleared Nov 10, 2021
Reverso
K212107 · GEI
Intelis Instruments , Ltd.
General & Plastic Surgery · 127d
Cleared Nov 09, 2021
BodySculp
K212331 · PKT
Rohrer Aesthetics, LLC
General & Plastic Surgery · 105d
Cleared Nov 09, 2021
Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT,...
K211517 · GEX
Convergent Laser Technologies
General & Plastic Surgery · 176d
Cleared Nov 05, 2021
CoolSculpting Elite System
K212707 · OOK
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 71d
Cleared Nov 05, 2021
Resonic Rapid Acoustic Pulse Device
K212502 · GEX
Soliton, Inc.
General & Plastic Surgery · 88d
Cleared Nov 05, 2021
SoftFix Balloon Trocar
K211577 · GCJ
Unimax Medical Systems, Inc.
General & Plastic Surgery · 168d
Cleared Nov 04, 2021
IPL Hair Removal Device, model: AI01
K212897 · OHT
Shenzhen Century Dongyuan Technology...
General & Plastic Surgery · 55d
Cleared Nov 04, 2021
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM...
K212511 · GCJ
Stryker
General & Plastic Surgery · 86d
Cleared Nov 04, 2021
7 Series Phototherapy Device
K212510 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 86d
Cleared Oct 29, 2021
VersaWrap
K213163 · FTM
Alafair Biosciences, Inc.
General & Plastic Surgery · 31d
Cleared Oct 29, 2021
TraumaGuard Intra-abdominal Pressure Sensing System
K210570 · PHU
Sentinel Medical Technologies, LLC
General & Plastic Surgery · 245d