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
2233–2256 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Feb 26, 2021
Laser Treatment System, Model: NYX and Grace
K210033 · GEX
Canadian Pioneer Medical Technology...
General & Plastic Surgery · 52d
Cleared Feb 26, 2021
IPL Hair removal
K203510 · OHT
Shenzhen Weikai Technology Co.,Ltd
General & Plastic Surgery · 88d
Cleared Feb 26, 2021
FLARE Single-Use Surgical Laser Fiber
K202702 · GEX
Realton (Suzhou) Medical Technology...
General & Plastic Surgery · 163d
Not Cleared Feb 26, 2021
Hominis Surgical System
DEN190022 · QNM
Momentis Surgical , Ltd.
General & Plastic Surgery · 681d
Cleared Feb 25, 2021
STOP U Model UXV Device
K203665 · PAY
Pollogen, Ltd.
General & Plastic Surgery · 71d
Cleared Feb 25, 2021
OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence...
K203578 · NQQ
Perimeter Medical Imaging Ai, Inc.
General & Plastic Surgery · 80d
Cleared Feb 25, 2021
Tixel System
K202988 · GEI
Novoxel , Ltd.
General & Plastic Surgery · 148d
Cleared Feb 24, 2021
4K UHD Laparoscope
K203255 · GCJ
Scivita Medical Technology Co., Ltd.
General & Plastic Surgery · 112d
Cleared Feb 24, 2021
Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
K200734 · PBY
Sirius Medical Systems B.V.
General & Plastic Surgery · 341d
Cleared Feb 23, 2021
Global Med Systems Milesman Compact Laser
K203804 · GEX
Global Med Systems SL
General & Plastic Surgery · 57d
Cleared Feb 23, 2021
Nissha Medical Technologies Neutral Electrodes
K203494 · GEI
Nissha Medical Technologies, Ltd.
General & Plastic Surgery · 88d
Cleared Feb 23, 2021
StitchKit COMBO
K202950 · GAM
Origami Surgical
General & Plastic Surgery · 146d
Cleared Feb 22, 2021
Surn5 Electrosurgical Argon Beam Generator and Accessories
K203522 · GEI
Surnic Corporation
General & Plastic Surgery · 83d
Cleared Feb 21, 2021
Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece
K202112 · PZL
Storz Medical AG
General & Plastic Surgery · 206d
Cleared Feb 19, 2021
CORE E3 Suction/irrigator
K202303 · GCJ
Conmed Corporation
General & Plastic Surgery · 189d
Cleared Feb 18, 2021
Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape
K201863 · NEU
Somatex Medical Technologies GmbH
General & Plastic Surgery · 227d
Cleared Feb 18, 2021
Demetra Analytics Toolkit
K201408 · PSN
Barco N.V.
General & Plastic Surgery · 266d
Cleared Feb 10, 2021
da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X...
K203632 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 61d
Cleared Feb 10, 2021
FORE-SIGHT ELITE Absolute Tissue Oximeter
K203490 · MUD
Edwards Lifesciences, LLC
General & Plastic Surgery · 75d
Cleared Feb 05, 2021
Antibacterial Bandage
K201324 · FRO
Jiangsu Excellence Medical Supplies...
General & Plastic Surgery · 263d
Cleared Feb 05, 2021
Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal...
K200320 · GDW
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 364d
Cleared Feb 02, 2021
CellFX System
K203299 · GEI
Pulse Biosciences, Inc.
General & Plastic Surgery · 85d
Cleared Feb 01, 2021
Monopolar Hook
K203603 · GCJ
Human Xtensions , Ltd.
General & Plastic Surgery · 54d
Cleared Feb 01, 2021
FAST-FIX FLEX
K203393 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 75d