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
2113–2136 of 18,368
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
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
Cleared Oct 28, 2021
Disposable Monopolar Laparoscopic Tips and Reusable Handles
K211019 · GEI
Dannik, LLC
General & Plastic Surgery · 206d
Cleared Oct 27, 2021
PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with...
K213125 · FTM
Synovis Life Technologies. Inc. (A...
General & Plastic Surgery · 30d
Cleared Oct 27, 2021
V.A.C.ULTA Negative Pressure Wound Therapy System
K203316 · OMP
Kci, A Part of 3M Health Care...
General & Plastic Surgery · 351d
Cleared Oct 27, 2021
The Alma Opus System, Colibri Applicator and Tips
K201520 · GEI
Alma Lasers, Inc.
General & Plastic Surgery · 506d
Cleared Oct 26, 2021
Medical Diode Laser Systems
K211977 · GEX
Wuhan Dimed Laser Technology Co., Ltd.
General & Plastic Surgery · 123d
Cleared Oct 26, 2021
Vydence Zye and Vydence One
K202998 · GEX
Vydence Medical Industria E Comercio...
General & Plastic Surgery · 390d
Cleared Oct 25, 2021
Titan Manufacturing Bipolar Forceps
K213386 · GEI
Titan Manufacturing, Inc.
General & Plastic Surgery · 12d
Cleared Oct 25, 2021
Laser Treatment System, Model: Hera, Armo
K212793 · GEX
Canadian Pioneer Medical Technology...
General & Plastic Surgery · 54d
Cleared Oct 25, 2021
Arthrex LoopLoc Knotless Suture
K212146 · GAT
Arthrex, Inc.
General & Plastic Surgery · 108d
Cleared Oct 25, 2021
Ultrasonic Surgical & Electrosurgical Generator
K210488 · GEI
Surgnova Healthcare Technologies...
General & Plastic Surgery · 248d
Cleared CT Oct 22, 2021
Aveli
K212399 · OUP
Nc8, Inc.
General & Plastic Surgery · 81d
Cleared Oct 22, 2021
CO2 Laser Machine, Model: BW-203B
K211735 · GEX
Zhengzhou Bestview ST Co., Ltd.
General & Plastic Surgery · 137d
Cleared Oct 22, 2021
CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit
K210310 · GEH
Nuance Medical, LLC
General & Plastic Surgery · 261d
Cleared Oct 21, 2021
IPL Hair Removal Device
K212314 · OHT
Zhongshan Bisen Plastic Electronic...
General & Plastic Surgery · 90d
Cleared Oct 21, 2021
DEKA LipoAI
K212270 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 93d
Cleared Oct 21, 2021
Portable Scalp Cooling System
K211526 · PMC
Cooler Heads Care, Inc.
General & Plastic Surgery · 157d