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
1057–1080 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Apr 01, 2024
ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag,...
K240635 · GCJ
Ximedica
General & Plastic Surgery · 26d
Cleared Mar 29, 2024
SmoothSkin Pure Unplugged (SSB3)
K240587 · OHT
Cyden Limited
General & Plastic Surgery · 28d
Cleared Mar 28, 2024
Emprint Ablation System with Thermosphere Technology (Overall System Name)
K233838 · NEY
Medtronic, Inc.
General & Plastic Surgery · 115d
Cleared Mar 28, 2024
BTL-785S
K233604 · GEI
BTL Industries, Inc.
General & Plastic Surgery · 140d
Cleared Mar 27, 2024
Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 )
K240389 · NEW
Hyundae Meditech Co., Ltd.
General & Plastic Surgery · 48d
Cleared Mar 27, 2024
LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial...
K223360 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 510d
Not Cleared Mar 27, 2024
Medline ART Skin Harvesting System
DEN210049 · QYK
Medline Industries, Inc.
General & Plastic Surgery · 890d
Cleared Mar 26, 2024
PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound...
K233151 · FRO
Medline Industries, LP
General & Plastic Surgery · 181d
Cleared Mar 22, 2024
Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in)
K231953 · FRO
Coloplast Corp.
General & Plastic Surgery · 266d
Cleared Mar 21, 2024
Medical Diode Laser (Model: L2)
K240179 · GEX
Wuhan Pioon Technology Co., Ltd.
General & Plastic Surgery · 58d
Cleared Mar 21, 2024
RedDrop ONE (One)
K234081 · FMK
Reddrop DX
General & Plastic Surgery · 90d
Cleared Mar 20, 2024
SMARTXIDE PRO
K240537 · GEX
El.En S.P.A.
General & Plastic Surgery · 23d
Cleared Mar 20, 2024
EXPLORER AIR® II (8001, 8002, 8003)
K234090 · IZI
Surgvision GmbH
General & Plastic Surgery · 89d
Cleared Mar 20, 2024
InMode RF System
K233642 · GEI
Inmode , Ltd.
General & Plastic Surgery · 128d
Cleared Mar 20, 2024
BEED 2,5, BEED 3,8
K233002 · GEI
Excelsior Resources, LLC
General & Plastic Surgery · 180d
Cleared Mar 16, 2024
Meriglu Topical Skin Adhesive
K230981 · MPN
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 346d
Cleared Mar 15, 2024
RESPONDER® Polysaccharide Hemostat
K240454 · QSY
Starch Medical, Inc.
General & Plastic Surgery · 29d
Cleared Mar 15, 2024
PICOANDY (Q-Switched Nd:YAG Laser)
K234104 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 80d
Cleared Mar 15, 2024
Intensity Pulsed Light Therapy System
K233307 · ONF
Beijing Adss Development Co., Ltd.
General & Plastic Surgery · 168d
Cleared Mar 14, 2024
da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with...
K232610 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 199d
Cleared Mar 14, 2024
Define RF Microneedling System
K232301 · GEI
Aesthetic Management Partners
General & Plastic Surgery · 226d
Cleared Mar 13, 2024
Edison System
K233466 · QGM
HistoSonics, Inc.
General & Plastic Surgery · 141d
Cleared Mar 12, 2024
Smartxide Tetra Pro
K240497 · GEX
El.En S.P.A.
General & Plastic Surgery · 21d
Cleared Mar 12, 2024
EmoLED (v. 2-USA)
K240132 · GEX
Emoled, Srl
General & Plastic Surgery · 55d