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
2737–2760 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2019
SignalMark Breast Marker
K190689 · NEU
View Point Medical, Inc.
General & Plastic Surgery · 149d
Cleared Aug 09, 2019
SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium...
K183647 · GEX
Olympus Surgical Technologies America
General & Plastic Surgery · 226d
Cleared Aug 08, 2019
Erchonia EVRL
K191257 · NHN
Erchonia Corporation
General & Plastic Surgery · 90d
Cleared Aug 06, 2019
Percutaneous Introducer Needle
K191295 · GCJ
Progressive Medical, Inc.
General & Plastic Surgery · 84d
Cleared Aug 02, 2019
Primelase Excellence
K191321 · GEX
High Technology Products S.L.U
General & Plastic Surgery · 79d
Cleared Jul 31, 2019
GORE BIO-A Tissue Reinforcement
K191773 · OWT
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 29d
Cleared Jul 31, 2019
Diode Laser Therapy Systems
K191611 · GEX
Wingderm Electro-Optics , Ltd.
General & Plastic Surgery · 44d
Cleared Jul 31, 2019
Fluobeam LX
K190891 · QDG
Fluoptics
General & Plastic Surgery · 117d
Cleared Jul 31, 2019
DemeTECH DemeFORCE Nonabsorbable Surgical Suture
K190777 · GAT
Demetech Corporation
General & Plastic Surgery · 127d
Cleared Jul 30, 2019
Renuvion/J-Plasma Precise Handpiece
K191484 · GEI
Apyx Medical Corporation(Formerly...
General & Plastic Surgery · 56d
Cleared Jul 29, 2019
BiomarC Fiducial Marker
K191797 · IYE
Carbon Medical Technologies
General & Plastic Surgery · 26d
Cleared Jul 29, 2019
Hair Boom 69
K191154 · OAP
Wontech
General & Plastic Surgery · 89d
Cleared Jul 26, 2019
da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30
K191736 · NAY
Intuitive Surgical
General & Plastic Surgery · 28d
Cleared Jul 26, 2019
The ZIP Accessory Shuttle for PleuraFlow System
K191733 · OTK
Clearflow, Inc.
General & Plastic Surgery · 28d
Cleared Jul 26, 2019
ScanX Barrier Envelopes
K190949 · PEM
Air Techniques, Inc.
General & Plastic Surgery · 106d
Cleared Jul 26, 2019
Hair Growth System
K190685 · OAP
Xuzhou Kernel Medical Equipment Co.,...
General & Plastic Surgery · 130d
Cleared Jul 25, 2019
Silicone PHMB Foam Wound Dressing
K190819 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 115d
Cleared Jul 24, 2019
TempSure
K190678 · GEI
Cynosure, Inc.
General & Plastic Surgery · 128d
Cleared Jul 19, 2019
NvisionVLE Low-profile Optical Probe
K191117 · NQQ
Ninepoint Medical, Inc.
General & Plastic Surgery · 84d
Cleared Jul 19, 2019
Exceed Microneedling device
K182407 · QAI
Mt. Derm GmbH
General & Plastic Surgery · 318d
Cleared Jul 18, 2019
MONTAGE-QS Settable, Resorbable Hemostatic Bone
K191140 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 79d
Cleared Jul 18, 2019
Silverlon Wound Contact, Burn Contact Dressings
K190343 · FRO
Argentum Medical, LLC
General & Plastic Surgery · 154d
Cleared Jul 17, 2019
Pegasus System
K191345 · HRX
A.M. Surgical, Inc.
General & Plastic Surgery · 58d
Cleared Jul 17, 2019
Powersculp laser lipolysis system
K191068 · PKT
Wuhan Lotuxs Technology Co., Ltd.
General & Plastic Surgery · 86d