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
1993–2016 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Dec 16, 2021
Voyant Fine Fusion Device (EB230)
K202818 · GEI
Applied Medical
General & Plastic Surgery · 448d
Cleared Dec 15, 2021
Cellusheet, Cellufil
K213092 · KGN
Human Biosciences, Inc.
General & Plastic Surgery · 82d
Cleared Dec 15, 2021
reVive Light Therapy Essentials
K210965 · OHS
Led Technologies, Inc.
General & Plastic Surgery · 259d
Cleared Dec 15, 2021
Innomed NPWT Silicone Foam Dressing
K202823 · OMP
Zhejiang Longterm Medical Technology...
General & Plastic Surgery · 447d
Cleared Dec 14, 2021
Instant 20s Indicator
K210481 · MTC
True Indicating, LLC
General & Plastic Surgery · 298d
Cleared Dec 14, 2021
PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use...
K203716 · QFC
Smith and Nephew Medical Limited
General & Plastic Surgery · 358d
Cleared Dec 14, 2021
S2 Pigment Removal System
K202848 · GEX
Lightsense Technologies, Ltd.
General & Plastic Surgery · 445d
Cleared Dec 13, 2021
neXus Ultrasonic Surgical Aspirator System
K212060 · LFL
Misonix, Inc.
General & Plastic Surgery · 165d
Cleared Dec 10, 2021
8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30...
K211997 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 165d
Cleared Dec 10, 2021
UltraClear Fractional Laser System
K210847 · GEX
Fa International, LP
General & Plastic Surgery · 263d
Cleared Dec 10, 2021
i8 Tanning Booth
K210004 · FTC
Ultrasun International B.V.
General & Plastic Surgery · 340d
Cleared Dec 09, 2021
Plasma IQ
K212329 · GEI
Neauvia North America, Inc.
General & Plastic Surgery · 135d
Cleared Dec 08, 2021
PicoLO Premium
K212573 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 114d
Cleared Dec 07, 2021
DERMABOND PRINEO Skin Closure System
K213512 · OMD
Ethicon, Inc.
General & Plastic Surgery · 35d
Cleared Dec 03, 2021
Solero Microwave Tissue Ablation (MTA) System and Accessories
K213067 · NEY
AngioDynamics, Inc.
General & Plastic Surgery · 71d
Cleared Dec 03, 2021
ArtiSential Trocar
K212500 · GCJ
Livsmed, Inc.
General & Plastic Surgery · 116d
Cleared Dec 03, 2021
Medline Cardiovascular Procedure Kit
K212258 · LRO
Medline Industries, Inc.
General & Plastic Surgery · 136d
Not Cleared Dec 03, 2021
Klox Biophotonic LumiHeal System
DEN200005 · QPE
Klox Technlogies, Inc.
General & Plastic Surgery · 668d
Cleared Dec 02, 2021
FUJIFILM Video Laparoscope EL-R740M30
K212950 · GCJ
Fujifilm Corporaton
General & Plastic Surgery · 77d
Cleared Dec 02, 2021
Aimanfun Lumea Comfort, A-2789/A-3588
K212907 · ONF
Kam Yuen Plastic Products , Ltd.
General & Plastic Surgery · 80d
Cleared Dec 02, 2021
OxyLight 2.0
K202175 · GEX
Raja Trading Company, Inc.
General & Plastic Surgery · 485d
Cleared Nov 29, 2021
C2 CryoBalloon Ablation System
K212814 · GEH
Pentax of America, Inc.
General & Plastic Surgery · 87d
Cleared Nov 24, 2021
MicroPen EVO
K212558 · QAI
Eclipse Medcorp, LLC
General & Plastic Surgery · 103d
Cleared Nov 23, 2021
MZ Skin LightMAX Supercharged LED Mask 2.0
K213184 · OLP
Mz Skin
General & Plastic Surgery · 55d