Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General & Plastic Surgery ×
18,368 results
2089–2112 of 18,368
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
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
Cleared Nov 23, 2021
da Vinci SP Firefly Imaging System
K212101 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 140d
Cleared Nov 23, 2021
Virtue RF
K211562 · GEI
ShenB Co., Ltd.
General & Plastic Surgery · 187d
Cleared Nov 22, 2021
VS3 Iridium Sytem
K210265 · OWN
Visionsense, Ltd.
General & Plastic Surgery · 294d
Cleared Nov 19, 2021
Arthrex Vortex Threaded Bone Marrow Recovery Needle
K213213 · KNW
Arthrex, Inc.
General & Plastic Surgery · 51d
Cleared Nov 19, 2021
Leaf Smooth
K212697 · OHT
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Nov 19, 2021
Finebeam
K202288 · GEX
Snj Co., Ltd.
General & Plastic Surgery · 464d
Cleared Nov 18, 2021
IPL Hair Removal, Model: OBT-02
K213041 · OHT
Glan Electronics Co., Ltd.
General & Plastic Surgery · 57d
Cleared Nov 18, 2021
Dermalux Flex MD
K212275 · OHS
Aesthetic Technology, Ltd.
General & Plastic Surgery · 121d
Cleared Nov 15, 2021
KARL STORZ ICG Imaging System
K212695 · OWN
Karl Storz Endoscopy America
General & Plastic Surgery · 82d
Cleared Nov 15, 2021
Darwin
K212607 · GEX
Luvo Medical Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Nov 15, 2021
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
K212301 · LFL
Covidien, LLC
General & Plastic Surgery · 115d
Cleared Nov 15, 2021
SofWave System
K211483 · OHV
Sofwave Medical, Ltd.
General & Plastic Surgery · 187d
Cleared Nov 10, 2021
Diode laser therapy system
K212978 · GEX
Beijing Unt Technology Co., Ltd.
General & Plastic Surgery · 54d
Cleared Nov 10, 2021
Reverso
K212107 · GEI
Intelis Instruments , Ltd.
General & Plastic Surgery · 127d
Cleared Nov 09, 2021
BodySculp
K212331 · PKT
Rohrer Aesthetics, LLC
General & Plastic Surgery · 105d
Cleared Nov 09, 2021
Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT,...
K211517 · GEX
Convergent Laser Technologies
General & Plastic Surgery · 176d