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
2353–2376 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Oct 08, 2020
SilverStream Gel
K200767 · FRO
Enzysurge , Ltd.
General & Plastic Surgery · 197d
Cleared Oct 06, 2020
CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30,...
K202114 · GEI
Bolder Surgical, LLC
General & Plastic Surgery · 68d
Cleared Oct 02, 2020
Arthrex SoftStitch
K190707 · GAT
Arthrex, Inc.
General & Plastic Surgery · 563d
Cleared Sep 28, 2020
Electrosurgical Generator
K201221 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 145d
Cleared Sep 28, 2020
da Vinci SP Surgical System
K192717 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 367d
Cleared Sep 25, 2020
Restrata®
K193583 · QSZ
Acera Surgical, Inc.
General & Plastic Surgery · 277d
Cleared Sep 24, 2020
Dermal Cooling System
K201260 · GEH
R2 Technologies, Inc.
General & Plastic Surgery · 136d
Cleared Sep 18, 2020
Ran-Flex-B Bone Marrow Aspiration Needle
K202287 · KNW
Ranfac Corporation
General & Plastic Surgery · 37d
Cleared Sep 18, 2020
Electrosurgical Generator and Accessories
K201224 · GEI
Medrange
General & Plastic Surgery · 135d
Cleared Sep 10, 2020
HS Fiber
K202242 · GAT
Riverpoint Medical, LLC
General & Plastic Surgery · 31d
Cleared Sep 10, 2020
SubNovii Advanced Plasma Technology
K201738 · GEI
Cartessa Aesthetics
General & Plastic Surgery · 77d
Cleared Sep 10, 2020
Diode Laser Body Sculpture System
K201731 · PKT
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 78d
Cleared Sep 09, 2020
MINT Product Family
K192423 · NEW
Hans Biomed Corporation
General & Plastic Surgery · 371d
Cleared Sep 04, 2020
Arthrex NanoScope System
K201134 · GCJ
Arthrex, Inc.
General & Plastic Surgery · 129d
Cleared Sep 04, 2020
3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad
K200835 · FRO
3M Company
General & Plastic Surgery · 157d
Cleared Sep 04, 2020
MEBO Wound Dressing
K193439 · FRO
Mebo Life Science, Inc.
General & Plastic Surgery · 268d
Cleared Sep 03, 2020
Cliq Aspirator
K201203 · BTA
Anest Iwata Sparmax Co., Ltd.
General & Plastic Surgery · 122d
Cleared Sep 03, 2020
HaloGUARD Protective Disc with CHG
K200641 · FRO
Attwill Medical Solutions
General & Plastic Surgery · 176d
Cleared Sep 03, 2020
Lyograft
K192452 · FTM
B. Bruan Surgical, SA
General & Plastic Surgery · 360d
Cleared Sep 02, 2020
Aesculap PAS-Port Proximal Anastomosis System
K202124 · FZP
Aesculap, Inc.
General & Plastic Surgery · 33d
Cleared Sep 02, 2020
ApolloVue S100 Image System
K201552 · NQQ
Apollo Medical Optics, Ltd.
General & Plastic Surgery · 84d
Cleared Sep 01, 2020
CAPOGEN Laser Cap
K201854 · OAP
Nature, Inc.redible, Inc.
General & Plastic Surgery · 57d
Cleared Aug 29, 2020
Masimo O3 Regional Oximeter System
K201432 · MUD
Masimo Corporation
General & Plastic Surgery · 89d
Cleared Aug 28, 2020
OrthoGold 100
K200926 · PZL
Tissue Regeneration Technologies, LLC
General & Plastic Surgery · 143d