Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General & Plastic Surgery ×
18,368 results
1561–1584 of 18,368
Search insights Median review: 84d Cleared: 100% Top manufacturer: Intuitive Surgical, Inc. Lead specialty: General & Plastic Surgery
Cleared Mar 21, 2023
Retraction, CWM-910T, APOLEX Tite
K222709 · GEI
Chungwoo Co., Ltd.
General & Plastic Surgery · 194d
Cleared Mar 21, 2023
EasyTouch Lancing Device
K222617 · QRK
Stat Medical Devices
General & Plastic Surgery · 203d
Cleared Mar 21, 2023
OviTex PRS (Long Term Resorbable)
K214070 · FTM
Tela Bio
General & Plastic Surgery · 449d
Cleared Mar 20, 2023
Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B,...
K222828 · GCJ
Wickimed (Huizhou) Medical Equipment...
General & Plastic Surgery · 182d
Cleared Mar 20, 2023
HPR45i
K220725 · GEI
F Care Systems USA, LLC
General & Plastic Surgery · 371d
Cleared Mar 16, 2023
Senhance Surgical System
K223095 · NAY
Asensus Surgical, Inc.
General & Plastic Surgery · 167d
Cleared Mar 16, 2023
EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System,...
K222839 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 177d
Cleared Mar 16, 2023
Sterile Silver Alginate Wound Dressing
K220673 · FRO
Qingdao Bright Moon Biomedical...
General & Plastic Surgery · 374d
Cleared Mar 15, 2023
LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)
K230124 · OHS
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 57d
Cleared Mar 15, 2023
ECHELON LINEAR™ 60 mm Cutter (GLC60)
K223760 · GDW
Ethicon Endo-Surgery
General & Plastic Surgery · 90d
Cleared Mar 14, 2023
SofWave System
K230019 · OHV
Sofwave Medical, Ltd.
General & Plastic Surgery · 70d
Cleared Mar 14, 2023
JETT PLASMA Medical II
K213247 · QVJ
Compex, Spol, S.R.O.
General & Plastic Surgery · 530d
Cleared Mar 10, 2023
FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
K221623 · GEX
Gme (German Medical Engineering) GmbH
General & Plastic Surgery · 277d
Cleared Mar 09, 2023
LED Lip Perfector, model: ZC-05
K223642 · ILY
Light Tree Ventures Europe B.V.
General & Plastic Surgery · 93d
Cleared Mar 08, 2023
Enhanced AURORA™ Medical Diode System, and related accessories
K230076 · FTC
Psoria-Shield, Inc.
General & Plastic Surgery · 57d
Cleared Mar 08, 2023
extriCARE 1000 Negative Pressure Wound Therapy System
K213906 · OMP
Alleva Medical, Ltd.
General & Plastic Surgery · 449d
Cleared Mar 07, 2023
Solero Microwave Tissue Ablation (MTA) System and Accessories
K221883 · NEY
AngioDynamics, Inc.
General & Plastic Surgery · 251d
Cleared Mar 07, 2023
MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT...
K220549 · NEW
Hans Biomed Corporation
General & Plastic Surgery · 375d
Cleared Mar 03, 2023
Light Based Hair Removal Device GP592
K230060 · OHT
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 53d
Cleared Mar 02, 2023
Plasma Pen (Plasma MD)
K223440 · QVJ
Plasma Concepts
General & Plastic Surgery · 108d
Cleared Mar 02, 2023
Tenderfoot
K223352 · FMK
Accriva Diagnostics, Inc.
General & Plastic Surgery · 120d
Cleared Mar 01, 2023
Alma Harmony
K230308 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 26d
Cleared Mar 01, 2023
RSHOCK
K220014 · PBX
Swims America Corp
General & Plastic Surgery · 420d
Cleared Feb 28, 2023
IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06...
K223618 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 85d