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
3889–3912 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared May 26, 2016
Radiance Ultra Series ZeroWire Embedded
K161228 · GCJ
Nds Surgical Imaging, LLC
General & Plastic Surgery · 24d
Cleared May 26, 2016
Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug
K161221 · FTM
Cook Biotech Incorporated
General & Plastic Surgery · 27d
Cleared May 26, 2016
Noxilizer Surgical Ruler
K160501 · FTY
Noxilizer, Inc.
General & Plastic Surgery · 93d
Cleared May 26, 2016
AdTec
K160393 · GCJ
Aesculap, Inc.
General & Plastic Surgery · 105d
Cleared May 25, 2016
Prometheus ChitoGauze XR PRO
K153582 · QSY
Hem Con Medical Technologies, Inc.
General & Plastic Surgery · 162d
Cleared May 23, 2016
ARTOURA Breast Tissue Expanders with Smooth Surface
K161176 · LCJ
Mentor Worldwide, LLC
General & Plastic Surgery · 27d
Cleared May 23, 2016
Agem Ag Mesh Dressing with Silver
K152544 · FRO
Shenzhen Yuanxing Nano-Pharma Co., Ltd.
General & Plastic Surgery · 262d
Cleared May 23, 2016
PINPOINT Endoscopic Fluorescence Imaging System
K150956 · GCJ
Novadaq Technologies, Inc.
General & Plastic Surgery · 410d
Cleared May 20, 2016
CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with...
K160416 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 94d
Cleared May 20, 2016
Sunfire 32 Tanning Bed
K152423 · LEJ
Sunfire Industries, Inc.
General & Plastic Surgery · 268d
Cleared May 19, 2016
C2 CryoBalloon Focal Pear Catheter
K160994 · GEH
C2 Therapeutics, Inc.
General & Plastic Surgery · 41d
Cleared May 19, 2016
Valleylab REM Polyhesive Infant Patient Return Electrode
K160290 · GEI
Covidien, LLC
General & Plastic Surgery · 106d
Cleared May 19, 2016
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS...
K152842 · JCT
Boston Scientific Corporation
General & Plastic Surgery · 233d
Cleared May 19, 2016
Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200
K152452 · LEJ
Medtek Lighting Corp D/B/A Peacock...
General & Plastic Surgery · 265d
Cleared May 19, 2016
Filbloc
K150553 · NEW
Assut Europe
General & Plastic Surgery · 442d
Cleared May 18, 2016
Stryker SDC3 HD Information Management System with Wireless Device Control...
K160332 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 100d
Cleared May 18, 2016
Vario 8/18/ci
K153663 · BTA
Medela AG
General & Plastic Surgery · 149d
Cleared May 17, 2016
PicoSure Workstation
K160480 · GEX
Cynosure, Inc.
General & Plastic Surgery · 85d
Cleared May 13, 2016
Perimeter Otis™ 1.0 Optical Coherence Tomography System
K160240 · NQQ
Perimeter Medical Imaging, Inc.
General & Plastic Surgery · 102d
Cleared May 13, 2016
Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix...
K153236 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 186d
Cleared May 13, 2016
UltraCor Twirl Breast Tissue Marker
K152510 · NEU
Bard Peripheral Vascular, Inc.
General & Plastic Surgery · 254d
Cleared May 12, 2016
Laser Helmet LH40-EVO
K161046 · OAP
Theradome, Inc.
General & Plastic Surgery · 29d
Cleared May 12, 2016
Genteel Lancing Device
K153670 · FMK
Genteel, LLC
General & Plastic Surgery · 143d
Cleared May 09, 2016
True HD 3MOS Camera System
K161017 · GCJ
Conmed Corporation
General & Plastic Surgery · 27d