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
3241–3264 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Feb 13, 2018
Voyant 5mm Fusion Device
K172624 · GEI
Applied Medical Resources Corporation
General & Plastic Surgery · 165d
Cleared Feb 13, 2018
Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical...
K171825 · GEI
Hunan Handlike Minimally Invasive...
General & Plastic Surgery · 239d
Cleared Feb 12, 2018
Home Use Hair Removal Device/T1, T2, T3
K172883 · OHT
Shenzhen Mareal Tech Co., Ltd.
General & Plastic Surgery · 144d
Cleared Feb 09, 2018
Ergonomic Handle
K173272 · GCJ
Symmetry Surgical, Inc.
General & Plastic Surgery · 120d
Cleared Feb 08, 2018
Gazelle PTFE and Suture Delivery Device
K173335 · NBY
Dura Tap, LLC
General & Plastic Surgery · 108d
Cleared Feb 07, 2018
PicoSure Workstation
K173199 · GEX
Cynosure, Inc.
General & Plastic Surgery · 128d
Cleared Feb 02, 2018
SMAXEL CO2 Surgical Laser System
K180036 · ONG
Ids, Ltd.
General & Plastic Surgery · 28d
Cleared Feb 02, 2018
PICO 7 Single Use Negative Pressure Wound Therapy System
K172005 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 214d
Cleared Feb 01, 2018
AEON Endoscopic Stapler
K173443 · GDW
Lexington Medical, Inc.
General & Plastic Surgery · 87d
Cleared Feb 01, 2018
Specimen Retrieval Bag
K172789 · GCJ
Beijing Hangtian Kadi Technology R&D...
General & Plastic Surgery · 139d
Cleared Feb 01, 2018
Duatene bilayer mesh
K172395 · FTL
Sofradim Production
General & Plastic Surgery · 177d
Cleared Feb 01, 2018
MERISTEEL
K172146 · GAQ
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 199d
Cleared Jan 31, 2018
AtriClip FLEX-V
K180010 · FZP
AtriCure, Inc.
General & Plastic Surgery · 29d
Cleared Jan 31, 2018
da Vinci Xi Surgical System
K172643 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 152d
Cleared Jan 30, 2018
Luma Light System
K173436 · FTC
Luma Therapeutics
General & Plastic Surgery · 88d
Cleared Jan 30, 2018
Rex Medical Aspiration Pump
K173389 · BTA
Rex Medical, L.P.
General & Plastic Surgery · 92d
Cleared Jan 30, 2018
Irradiation Aesthetic Device
K171835 · OAP
Chongqing Peninsula Medical...
General & Plastic Surgery · 224d
Cleared Jan 29, 2018
JOULE SYSTEM
K173285 · GEX
Sciton, Inc
General & Plastic Surgery · 105d
Cleared Jan 26, 2018
illumiflow 148 Laser Cap
K173843 · OAP
Eglobal, LLC
General & Plastic Surgery · 39d
Cleared Jan 26, 2018
Stryker 90-S Max SERFAS Energy Probe
K171391 · GEI
Stryker
General & Plastic Surgery · 260d
Cleared Jan 24, 2018
SUNTOUCH Dental Dressing
K173196 · OLR
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 114d
Cleared Jan 23, 2018
C2 CryoBalloon Ablation System
K163684 · GEH
C2 Therapeutics, Inc.
General & Plastic Surgery · 391d
Cleared Jan 18, 2018
Stryker AIM Light Source and SafeLight cable
K173866 · OWN
Stryker
General & Plastic Surgery · 29d
Cleared Jan 18, 2018
Lumilisse IPL Hair Remover
K172791 · OHT
Conair Corporation
General & Plastic Surgery · 125d