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
3025–3048 of 18,288
Search insights Median review: 84d Cleared: 100% Top manufacturer: Ethicon, Inc. Lead specialty: General & Plastic Surgery
Cleared Sep 07, 2018
AMSure Sterile Water, and Sterile Normal Saline for Wound Flush
K181423 · FRO
Amsino International, Inc.
General & Plastic Surgery · 99d
Cleared Sep 07, 2018
Exceed Microneedling Device
K180778 · QAI
Mt. Derm GmbH
General & Plastic Surgery · 165d
Cleared Sep 07, 2018
IPL Hair Removal Device Joy Version
K173813 · OHT
Shen Zhen Cosbeauty Co., Ltd.
General & Plastic Surgery · 266d
Cleared Sep 06, 2018
Sebacia Microparticles
K181518 · QCY
Sebacia, Inc.
General & Plastic Surgery · 90d
Cleared Sep 05, 2018
Kiierr 272 Laser, Kiierr 148 Laser
K181878 · OAP
Kiierr International, LLC
General & Plastic Surgery · 54d
Cleared Sep 04, 2018
ECHOLASER X4
K181510 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 88d
Cleared Sep 04, 2018
EUSRA RF Electrode
K181249 · GEI
Starmed Co., Ltd.
General & Plastic Surgery · 117d
Cleared Aug 30, 2018
Dissecting Balloon System
K182024 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 31d
Cleared Aug 30, 2018
DEKA Motus AY
K181486 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 85d
Cleared Aug 30, 2018
LYFT
K180888 · OLP
Uplevity, Inc.
General & Plastic Surgery · 148d
Cleared Aug 29, 2018
Natrelle 133S Tissue Expander
K182054 · LCJ
Allergan
General & Plastic Surgery · 29d
Cleared Aug 29, 2018
ZELTIQ CoolSculpting System
K181740 · OOK
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 58d
Cleared Aug 29, 2018
Geister retractor for neuro - and spine surgery
K180610 · GZT
Geister Medizin Technik GmbH
General & Plastic Surgery · 174d
Cleared Aug 28, 2018
Tenex Health TX System with the TXP MicroTip
K181367 · LFL
Tenex Health, Inc.
General & Plastic Surgery · 97d
Cleared Aug 27, 2018
DemeTECH DemeDIOX absorbable surgical suture
K181582 · NEW
Demetech Corporation
General & Plastic Surgery · 73d
Cleared Aug 21, 2018
MIDAScope and Introducer Kit, and MIDASystem
K181982 · HRX
Intravu, Inc.
General & Plastic Surgery · 27d
Cleared Aug 21, 2018
SIMPLYSTRONG, SIMPLYEZEE
K181791 · GCJ
Genicon, Inc.
General & Plastic Surgery · 47d
Cleared Aug 21, 2018
PICO 7 Single Use Negative Pressure Wound Therapy System
K180698 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 158d
Cleared Aug 20, 2018
BEXCORE Breast Biopsy System, Biopsy Needle
K171890 · KNW
Medical Park Co., Ltd.
General & Plastic Surgery · 420d
Cleared Aug 17, 2018
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
K181940 · OXC
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 29d
Cleared Aug 17, 2018
Simple Science Antimicrobial Facial and Eyelid Cleanser
K181074 · FRO
Simple Science, LLC
General & Plastic Surgery · 115d
Cleared Aug 15, 2018
SuperGrow 272, Ultimate 272
K181308 · OAP
Super Grow Lasers
General & Plastic Surgery · 90d
Cleared Aug 14, 2018
PleuraFlow System with FlowGlide Extra Drainage Length
K182067 · OTK
Clearflow, Inc.
General & Plastic Surgery · 13d
Cleared Aug 13, 2018
BIAFINE
K173549 · FRO
Valeant Pharmaceuticals
General & Plastic Surgery · 270d