FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
21841–21864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 2019
Reusable SpO2 Sensor
K191420 · DQA
Shenzhen Changke Connect Electronics...
Anesthesiology · 136d
Cleared Oct 11, 2019
Wet Water Based Personal Lubricant (additionally, branded as WET Platinum...
K191480 · NUC
Trigg Laboratories, Inc. D/B/A Wet...
Obstetrics & Gynecology · 129d
Cleared Oct 11, 2019
Apyx Plasma/RF Handpiece
K191542 · GEI
Bovie Medical Corporation Dba Apyx...
General & Plastic Surgery · 122d
Cleared Oct 11, 2019
Nexus Universal Self-Cure
K191548 · EMA
Kerr Corporation
Dental · 121d
Cleared Oct 11, 2019
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume...
K191684 · JXG
Integra LifeSciences Corporation
Neurology · 109d
Cleared Oct 11, 2019
Nano FortiCore, FortiCore
K191822 · ODP
Nanovis, LLC
Orthopedic · 95d
Cleared Oct 11, 2019
Razor, Everest, U&C Liquid
K191902 · EIH
U&C International Co., Ltd.
Dental · 87d
Cleared Oct 11, 2019
K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2”...
K192057 · FMI
Terumo Europe N.V.
General Hospital · 71d
Cleared Oct 11, 2019
CarboClear VBR System
K192214 · MQP
CarboFix Orthopedics , Ltd.
Orthopedic · 57d
Cleared Oct 11, 2019
AEON Laparoscopic Instruments
K192235 · GEI
Lexington Medical, Inc.
General & Plastic Surgery · 53d
Cleared Oct 11, 2019
Zimmer Natural Nail System Cephalomedullary Nails
K192312 · HSB
Zimmer GmbH
Orthopedic · 46d
Cleared Oct 11, 2019
BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20,...
K192515 · LDJ
Shenzhen Bioeasy Biotechnology Co., Ltd.
Toxicology · 28d
Cleared Oct 10, 2019
Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
K182136 · NUH
Shenzhen Osto Technology Co., Ltd.
Neurology · 430d
Cleared Oct 10, 2019
Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization...
K182184 · FRG
Mdk (Shanghai) Medical Packing Co., Ltd.
General Hospital · 423d
Cleared Oct 10, 2019
Waterlase Laser System Family
K190319 · GEX
Biolase, Inc.
General & Plastic Surgery · 239d
Cleared Oct 10, 2019
KTA Adipose Treatment Kit
K190386 · MUU
Stemics S.A.S
General & Plastic Surgery · 233d
Cleared Oct 10, 2019
Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory –...
K190523 · PJN
Ossdsign AB
Neurology · 220d
Cleared Oct 10, 2019
SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
K190772 · IZI
Olympus Medical Systems Corp.
Neurology · 198d
Cleared Oct 10, 2019
Palladium High Flow Therapy System
K191010 · BTT
Vapotherm, Inc.
Anesthesiology · 177d
Cleared Oct 10, 2019
Mercy babyTAPE
K191174 · PIR
Children'S Mercy Hospital
General Hospital · 162d
Cleared Oct 10, 2019
Belun Ring
K191417 · DQA
Belun Technology Company Limited
Anesthesiology · 135d
Cleared Oct 10, 2019
Legacy SMARTBase Abutments
K191458 · NHA
Implant Direct Sybron Manufacturing, LLC
Dental · 132d
Cleared Oct 10, 2019
Instylla Delivery Kit
K191659 · FMF
Instylla, Inc.
General Hospital · 111d
Cleared Oct 10, 2019
SMR Finned Short Stems
K191963 · MBF
Lima Corporate S.P.A.
Orthopedic · 79d