FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: General & Plastic Surgery ×
18,256 results
361–384 of 18,256
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2025
TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)
K251464 · GEX
Jeisys Medical Incorporated
General & Plastic Surgery · 143d
Cleared Oct 03, 2025
da Vinci SP Surgical System (SP1098)
K251426 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 148d
Cleared Oct 03, 2025
Revolve Surgical System
K243968 · GCJ
Revolve Surgical, Inc.
General & Plastic Surgery · 284d
Cleared Oct 03, 2025
HESTIA (L200-A)
K242946 · GEX
Senbitec Co., Ltd.
General & Plastic Surgery · 373d
Not Cleared Oct 03, 2025
ProSense™ System
DEN220077 · QXW
Icecure Medical
General & Plastic Surgery · 1080d
Cleared Oct 02, 2025
IPL Hair Removal Device (IPL-001, IPL-002)
K251398 · OHT
Shenzhen Enmind Technology Co., Ltd.
General & Plastic Surgery · 149d
Cleared Oct 02, 2025
4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
K250551 · GCJ
Shenzhen Sophway Technology Co., Ltd.
General & Plastic Surgery · 219d
Cleared Oct 01, 2025
Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP,...
K252804 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 28d
Cleared Oct 01, 2025
Picosecond laser device (BMPS4)
K252447 · GEX
Hebei Newangie Technology Co., Ltd.
General & Plastic Surgery · 58d
Cleared Oct 01, 2025
Light Therapy Decollete Mask (1019135)
K252096 · OHS
Merchsource, LLC
General & Plastic Surgery · 90d
Cleared Oct 01, 2025
E Blator
K251899 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 103d
Cleared Oct 01, 2025
Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)
K251825 · OHS
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 110d
Cleared Sep 30, 2025
Dexter L6 System
K251197 · SDD
Distalmotion SA
General & Plastic Surgery · 166d
Cleared Sep 29, 2025
NEW DOUBLO 2.0
K251334 · GEI
Hironic Co., Ltd.
General & Plastic Surgery · 152d
Cleared Sep 26, 2025
Magnetic Surgical System
K252435 · PNL
Levita Magnetics International Corp
General & Plastic Surgery · 56d
Cleared Sep 26, 2025
Thulium Laser System (Deluxlase)
K251919 · GEX
Nanjing Bestview Laser S&T Co., Ltd.
General & Plastic Surgery · 95d
Cleared Sep 25, 2025
Medical Diode Laser Systems (BERYLAS-12N)
K252063 · GEX
Wuhan Dimed Laser Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Sep 24, 2025
Resitu Slider 09 (RESL09)
K252183 · KNW
Resitu Medical AB
General & Plastic Surgery · 75d
Cleared Sep 24, 2025
Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories
K250071 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 257d
Cleared Sep 23, 2025
PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture
K252644 · NEW
M/s. Meril Endo Surgery Private Limited.
General & Plastic Surgery · 33d
Cleared Sep 23, 2025
Luminance Red Cold Sore Device (TN1927G)
K251973 · OKJ
Luminance Medical Ventures, Inc.
General & Plastic Surgery · 89d
Cleared Sep 22, 2025
SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System
K251743 · GCJ
Surgical Principals, Inc.
General & Plastic Surgery · 108d
Cleared Sep 22, 2025
IC-Flow™ Imaging System 2.0
K243645 · IZI
Diagnostic Green GmbH
General & Plastic Surgery · 300d
Cleared Sep 19, 2025
BondEase 2 Topical Skin Adhesive
K243990 · MPN
Optmed, Inc.
General & Plastic Surgery · 267d