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
2329–2352 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Nov 06, 2020
Medical RF
K192621 · GEI
Triworks Group Srl
General & Plastic Surgery · 410d
Cleared Nov 05, 2020
SPY-PHI System with SPY-PHI Fluorescence Assessment Software
K202244 · OWN
Novadaq Technologies Ulc. (Now A Part...
General & Plastic Surgery · 87d
Cleared Nov 03, 2020
Palm NRG cellulite and muscle toning body device
K191940 · PBX
Heat IN A Click
General & Plastic Surgery · 473d
Cleared Nov 02, 2020
IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX...
K203032 · GEH
Galil Medical, Inc.
General & Plastic Surgery · 28d
Cleared Nov 02, 2020
Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and...
K202562 · GEI
Ellusa, LLC
General & Plastic Surgery · 59d
Cleared Nov 02, 2020
Ellusa Bipolar Wands
K202558 · GEI
Ellusa, LLC
General & Plastic Surgery · 59d
Cleared Oct 30, 2020
Aesculap Caiman 5 Seal and Cut Technology System
K202938 · GEI
Aesculap, Inc.
General & Plastic Surgery · 30d
Cleared Oct 30, 2020
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use...
K202157 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 88d
Cleared Oct 28, 2020
Tri-Staple 2.0 Reloads
K202864 · GDW
Covidien
General & Plastic Surgery · 30d
Cleared Oct 28, 2020
Ultimate Contour, Ultimate Contour Mini
K201475 · PBX
CAO Group, Inc.
General & Plastic Surgery · 147d
Cleared Oct 28, 2020
NP1 Instrument, Creo Electrosurgical System
K200003 · NEY
Creo Medical, Ltd.
General & Plastic Surgery · 300d
Cleared Oct 23, 2020
SURGIPHOR Wound Irrigation System
K202071 · FQH
Orthophor, LLC
General & Plastic Surgery · 88d
Cleared Oct 23, 2020
PocketDoc™ Micro Wound Therapy System
K200223 · OMP
Pensar Medical, LLC
General & Plastic Surgery · 268d
Cleared Oct 22, 2020
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
K202428 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 58d
Cleared Oct 21, 2020
ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew...
K201884 · GEI
Microline Surgical, Inc.
General & Plastic Surgery · 105d
Cleared Oct 21, 2020
InnovaMatrix
K193552 · KGN
Triad Life Sciences, Inc.
General & Plastic Surgery · 306d
Cleared Oct 21, 2020
C4 Fiducial Marker
K192771 · NEU
C4 Imaging, LLC
General & Plastic Surgery · 387d
Cleared Oct 20, 2020
WEGO-PDO Barbed Suture
K201139 · NEW
Foosin Medical Supplies Inc., Ltd.
General & Plastic Surgery · 175d
Cleared Oct 19, 2020
anti-bacterial bandage
K200821 · FRO
Planet (Suzhou) Medical Products Co.,...
General & Plastic Surgery · 203d
Cleared Oct 16, 2020
Medline Smoke Evacuation Pencil
K201129 · GEI
Medline Industires, Inc.
General & Plastic Surgery · 171d
Cleared Oct 15, 2020
Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters,...
K202665 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 31d
Cleared Oct 15, 2020
Opera Evo
K202041 · GEX
Quanta System Spa
General & Plastic Surgery · 84d
Cleared Oct 09, 2020
AEON Endoscopic Stapler
K201882 · GDW
Lexington Medical, Inc.
General & Plastic Surgery · 93d
Cleared Oct 08, 2020
Adavanced Imaging Modality System (1688 4K Camera System With Advanced...
K202592 · GCJ
Stryker
General & Plastic Surgery · 30d