Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General & Plastic Surgery ×
18,368 results
1993–2016 of 18,368
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Mar 18, 2022
TempSure System
K212891 · GEI
Cynosure, LLC
General & Plastic Surgery · 189d
Cleared Mar 18, 2022
ARISTE AB Mesh
K211132 · FTL
Ariste Medical, LLC
General & Plastic Surgery · 336d
Cleared Mar 18, 2022
LYMA Laser
K210823 · OHS
Lyma Life , Ltd.
General & Plastic Surgery · 364d
Cleared Mar 17, 2022
Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use...
K210315 · GEI
Modern Medical Equipment...
General & Plastic Surgery · 407d
Cleared Mar 16, 2022
Fiber Dust PRO
K220426 · GEX
Quanta System Spa
General & Plastic Surgery · 30d
Cleared Mar 16, 2022
IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat...
K210528 · MUU
Millennium Medical Technologies Inc...
General & Plastic Surgery · 386d
Cleared Mar 11, 2022
Demetra Dermatoscope BDEM-01
K213957 · PSN
Barco N.V.
General & Plastic Surgery · 84d
Cleared Mar 11, 2022
PHantom Trilogy
K213534 · OLI
Resurgeonz, LLC
General & Plastic Surgery · 126d
Cleared Mar 11, 2022
Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar...
K213354 · GEI
Conmed Corporation
General & Plastic Surgery · 150d
Cleared Mar 09, 2022
4K UHD LCD Monitor OEV321UH
K220069 · GCJ
Olympus Medical Systems Corp.
General & Plastic Surgery · 58d
Cleared Mar 08, 2022
IPL Hair Removal Device
K213558 · ONF
Ulike Co., Ltd.
General & Plastic Surgery · 120d
Cleared Mar 08, 2022
Oclet TDS 1000
K212049 · LFL
Tendonova Corporation
General & Plastic Surgery · 251d
Cleared Mar 07, 2022
SkinPen Precision System
K220506 · QAI
Crown Aesthetics
General & Plastic Surgery · 13d
Cleared Mar 07, 2022
BTL-785W
K211639 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 284d
Cleared Mar 03, 2022
easy Claire
K213285 · OHS
Y & J Bio Co., Ltd.
General & Plastic Surgery · 153d
Cleared Mar 03, 2022
Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal...
K211811 · GDW
Wuxi Beien Surgery Device Co., Ltd.
General & Plastic Surgery · 265d
Cleared Mar 02, 2022
angioLOCK Polymer Ligating Clip
K220006 · FZP
A2 Medical Systems, LLC
General & Plastic Surgery · 57d
Cleared Mar 02, 2022
ReNew Disposable Scissor Tips
K213127 · GEI
Microline Surgical, Inc.
General & Plastic Surgery · 156d
Cleared Feb 25, 2022
Explorer Air II
K214097 · IZI
Surgvision GmbH
General & Plastic Surgery · 59d
Cleared Feb 25, 2022
Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares
K211722 · GEX
Canadian Pioneer Medical Technology...
General & Plastic Surgery · 266d
Cleared Feb 25, 2022
Cool-tip RF Ablation System E Series
K203150 · GEI
Covidien, LLC
General & Plastic Surgery · 491d
Cleared Feb 24, 2022
ArtiSential Laparoscopic Instruments-Electrodes
K220384 · GEI
Livsmed, Inc.
General & Plastic Surgery · 14d
Cleared Feb 24, 2022
PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing
K210135 · FRO
3M Healthcare Business Group
General & Plastic Surgery · 401d
Cleared Feb 22, 2022
PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical...
K212380 · NEW
Ethicon, Inc.
General & Plastic Surgery · 204d