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
2929–2952 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Dec 21, 2018
REXLENE
K173747 · GAW
Sm Eng Co., Ltd.
General & Plastic Surgery · 378d
Cleared Dec 14, 2018
AC5 Topical Gel
K182681 · FRO
Arch Therapeutics, Inc.
General & Plastic Surgery · 79d
Cleared Dec 14, 2018
SafeAir Telescopic Smoke Pencil
K182354 · GEI
Lina Medical Aps
General & Plastic Surgery · 107d
Cleared Dec 14, 2018
Phasix ST Mesh with Echo 2 Positioning System
K182008 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 140d
Cleared Dec 14, 2018
iCertainty
K181269 · DPW
Rfpi
General & Plastic Surgery · 214d
Cleared Dec 13, 2018
LaparoGuard
K182434 · GCJ
Mariner Endosurgery, Inc.
General & Plastic Surgery · 98d
Cleared Dec 13, 2018
BTL-FR2000
K180359 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 307d
Cleared Dec 12, 2018
enlighten III Laser System
K182997 · GEX
Cutera, Inc.
General & Plastic Surgery · 43d
Cleared Dec 12, 2018
Medline Cautery Electrode (SILICONE)
K182812 · GEI
Medline Industries, Inc.
General & Plastic Surgery · 70d
Cleared Dec 11, 2018
Magma Spark Pro (Magma Spark Plus, Alpha)
K183307 · GEX
Formatk Systems , Ltd.
General & Plastic Surgery · 13d
Cleared Dec 11, 2018
Intuitive Surgical Vessel Sealer Extend
K183107 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 33d
Cleared Dec 11, 2018
Mygen V-1000 RF System
K180999 · GEI
RF Medical Co., Ltd.
General & Plastic Surgery · 239d
Cleared Dec 10, 2018
SabreLine and SabreGuard Laser Fibers
K182831 · GEX
Coloplast Corp.
General & Plastic Surgery · 62d
Cleared Dec 10, 2018
LUTRONIC GENIUS Radiofrequency System
K180945 · GEI
Lutronic Corporation
General & Plastic Surgery · 243d
Cleared Dec 10, 2018
Procellera Composite Antibacterial Wound Dressing
K180533 · FRO
Vomaris Wound Care, Inc.
General & Plastic Surgery · 285d
Cleared Dec 07, 2018
CUSA Clarity Ultrasonic Surgical Aspirator System
K182809 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 65d
Cleared Dec 07, 2018
SignalMark Lung Biopsy Site Marker
K180175 · GDW
View Point Medical, Inc.
General & Plastic Surgery · 319d
Cleared Dec 06, 2018
Senhance Surgical System
K183098 · NAY
Transenterix, Inc.
General & Plastic Surgery · 29d
Cleared Dec 06, 2018
KerraContact Ag Perf Advanced Perforated Silver Wound Dressing
K182680 · FRO
Exciton Technologies, Inc.
General & Plastic Surgery · 71d
Cleared Dec 04, 2018
Endoform Reconstructive Template - Non Absorbable
K181935 · FTL
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 138d
Cleared Nov 30, 2018
Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System
K182663 · GEX
Finemec Co., Ltd.
General & Plastic Surgery · 66d
Cleared Nov 30, 2018
Advanced Skin Renewing Device
K182498 · ONG
Jiangsu Unimed Laser Technology Co.,...
General & Plastic Surgery · 79d
Cleared Nov 30, 2018
UNO Negative Pressure Wound Therapy System
K180840 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 245d
Cleared Nov 29, 2018
Device Electrosurgical Generator ESG-150
K182587 · GEI
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 70d