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
817–840 of 18,256
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Sep 20, 2024
MTONE EVO (MTONE EVO)
K240604 · GEX
M&T S.R.L.
General & Plastic Surgery · 200d
Cleared Sep 17, 2024
Robin's Egg
K240689 · OAP
Telebrands Corporation
General & Plastic Surgery · 188d
Cleared Sep 16, 2024
Liftendo
K241771 · GEX
Medical San Ind?stria DE Equipamentos...
General & Plastic Surgery · 88d
Cleared Sep 16, 2024
OneMark
K241762 · NEU
View Point Medical
General & Plastic Surgery · 88d
Cleared Sep 13, 2024
Revian Lyte (10011)
K242441 · OAP
Revian, Inc.
General & Plastic Surgery · 28d
Cleared Sep 13, 2024
Vitruvian Liposaber
K240188 · QPB
Black & Black Surgical, Inc.
General & Plastic Surgery · 233d
Cleared Sep 13, 2024
Microdacyn Wound Care Solution
K233399 · FRO
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 345d
Cleared Sep 12, 2024
CoolSculpting Elite System
K233732 · OOK
Zeltiq Aesthetics, Inc. (Acquired by...
General & Plastic Surgery · 296d
Cleared Sep 10, 2024
8mm SureForm 30 Curved-Tip Stapler
K241638 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 95d
Cleared Sep 09, 2024
FoLix
K242349 · GEX
Lumenis Be, Ltd.
General & Plastic Surgery · 32d
Cleared Sep 09, 2024
Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM,...
K241205 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 132d
Cleared Sep 06, 2024
COPRO 3
K241672 · GEX
Amt Engineering Co., Ltd.
General & Plastic Surgery · 87d
Cleared Sep 06, 2024
MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer
K241552 · MRD
Mentor Worldwide, LLC
General & Plastic Surgery · 98d
Cleared Sep 05, 2024
Cold Sore Device (QPZ-03)
K241155 · OKJ
Shenzhen Nuon Medical Equipment Co.,...
General & Plastic Surgery · 133d
Cleared Sep 03, 2024
Litho 60
K242251 · GEX
Quanta System Spa
General & Plastic Surgery · 34d
Cleared Aug 30, 2024
ODI-Tech
K241393 · MUD
Odi Medical AS
General & Plastic Surgery · 106d
Cleared Aug 29, 2024
IPL Hair Removal Device (JM-843, JM-865, JM-638)
K241881 · OHT
Shenzhen Junmei Technology Co., Ltd.
General & Plastic Surgery · 62d
Cleared Aug 29, 2024
SkinPen Precision Elite System
K241400 · QAI
Crown Aesthetics
General & Plastic Surgery · 104d
Cleared Aug 28, 2024
Safety Lancet
K242316 · FMK
Ningbo Medsun Medical Co., Ltd.
General & Plastic Surgery · 23d
Cleared Aug 28, 2024
da Vinci Handheld Camera
K241913 · GCJ
Intuitive Surgical Operations, Inc.
General & Plastic Surgery · 58d
Cleared Aug 26, 2024
FiAPC plus probes
K242044 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 45d
Cleared Aug 23, 2024
LightWalker Laser System Family
K242202 · GEX
Fotona D.O.O.
General & Plastic Surgery · 28d
Cleared Aug 21, 2024
Fraxel® FTX Laser System
K242142 · GEX
Solta Medical
General & Plastic Surgery · 30d
Cleared Aug 21, 2024
Kerecis Parvus (50207)
K241080 · KGN
Kerecis Limited
General & Plastic Surgery · 124d