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
49–72 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Jul 16, 2026
Skin Air Cooling System (QALF-01)
K261674 · GEX
Beijing Nubway S&T Co., Ltd.
General & Plastic Surgery · 56d
Cleared Jul 15, 2026
XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368,...
K261407 · OHS
Dongguan Miqiang Technology Co., Ltd.
General & Plastic Surgery · 77d
Cleared Jul 14, 2026
Universal Seal (5-12 mm)
K261249 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Jul 13, 2026
Volnewmer™
K253504 · GEI
Classys, Inc.
General & Plastic Surgery · 255d
Cleared Jul 10, 2026
Capenergy C Equipments RF C200 and C400 Drakarian
K253480 · PBX
Capenergy Medical S.L.
General & Plastic Surgery · 269d
Cleared Jul 09, 2026
Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable...
K261988 · NEW
Teleflex Medical, LLC
General & Plastic Surgery · 27d
Cleared Jul 06, 2026
Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)
K260122 · QRL
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 172d
Cleared Jul 02, 2026
Collagen Wound Powder
K260596 · KGN
Ventris Medical
General & Plastic Surgery · 128d
Cleared Jul 01, 2026
Chromix
K261473 · OHS
Termosalud S.L.
General & Plastic Surgery · 58d
Cleared Jul 01, 2026
EasyWhip Family
K261021 · GAT
Winter Innovations, Inc.
General & Plastic Surgery · 96d
Cleared Jul 01, 2026
THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS)
K254056 · GEI
Olympus Medical Systems Corp.
General & Plastic Surgery · 196d
Cleared Jul 01, 2026
Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT)
K253527 · GAG
Covidien, LLC
General & Plastic Surgery · 230d
Cleared Jun 26, 2026
Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7,...
K261253 · OAP
Ziree Co., Ltd.
General & Plastic Surgery · 71d
Cleared Jun 25, 2026
Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture
K253394 · GAM
Ethicon, Inc.
General & Plastic Surgery · 268d
Cleared Jun 24, 2026
HD Camera Head OLYMPUS CH-S200-08-LB
K261260 · FET
Olympus Medical Systems Corporation
General & Plastic Surgery · 69d
Cleared Jun 24, 2026
Microdacyn Wound Irrigation Solution
K261023 · FRO
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 86d
Cleared Jun 24, 2026
Endoform Dermal Template
K260669 · KGN
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 114d
Cleared Jun 24, 2026
ConvaVAC™ Negative Pressure Wound Therapy System
K253263 · OMP
Convatec Limited, Gdc Building
General & Plastic Surgery · 268d
Cleared Jun 24, 2026
SilverCeuticals® Antimicrobial Wound Gel
K251929 · FRO
Silverceuticals, Inc.
General & Plastic Surgery · 366d
Cleared Jun 23, 2026
CURASYS 2 (EMDN0003)
K253199 · OMP
CG Bio Co., Ltd.
General & Plastic Surgery · 270d
Cleared Jun 18, 2026
Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)
K261701 · GEX
Micro-Energy Medical Technology Co.,...
General & Plastic Surgery · 27d
Cleared Jun 18, 2026
LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)
K260946 · OHS
Guangdong Newdermo Biotech Co., Ltd.
General & Plastic Surgery · 87d
Cleared Jun 18, 2026
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
K260636 · GEI
Stryker Sustainability Solutions
General & Plastic Surgery · 112d
Cleared Jun 18, 2026
ECMT-100 WMD
K253521 · KGN
Ecm Therapeutics, Inc.
General & Plastic Surgery · 217d