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
25129–25152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 2018
re.t.a Reuseable Tampon Applicator
K180850 · HEB
Thinx, Inc.
Obstetrics & Gynecology · 140d
Cleared Aug 20, 2018
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
K181768 · NFT
Assure Tech. (Hangzhou) Co, Ltd.
Toxicology · 48d
Cleared Aug 20, 2018
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card
K181968 · NFT
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology · 27d
Cleared Aug 17, 2018
Optical Topography System ETG-4100
K172492 · DQA
Hitachi Healthcare Americas
Neurology · 365d
Cleared Aug 17, 2018
BTI Dental Implant System UnicCa
K173257 · DZE
B.T.I. Biotechnology Institute, Sl.
Dental · 311d
Cleared Aug 17, 2018
Biodegradable Nitrile Powder Free Examination Glove (Blue)
K173509 · LZA
Hartalega Sdn Bhd
General Hospital · 277d
Cleared Aug 17, 2018
NuBorne Infant Warmer
K173516 · FMT
International Biomedical
General Hospital · 276d
Cleared Aug 17, 2018
OsteoReady Dental Implant System
K173575 · DZE
Osteoready, LLC
Dental · 270d
Cleared Aug 17, 2018
Forest Dental Unit
K173608 · EIA
Forest Dental Products, Inc.
Dental · 269d
Cleared Aug 17, 2018
Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose...
K173638 · NBW
Bionime Corporation
Chemistry · 266d
Cleared Aug 17, 2018
Electronic Stethoscope DS3011A
K173663 · DQD
Imediplus, Inc.
Cardiovascular · 261d
Cleared Aug 17, 2018
Penumbra System Reperfusion Catheter JET 7
K173761 · NRY
Penumbra, Inc.
Neurology · 249d
Cleared Aug 17, 2018
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD...
K173773 · DXT
Bayer Medical Care, Inc.
Cardiovascular · 248d
Cleared Aug 17, 2018
VersaPAP Positive Airway Pressure (PAP) Device
K173918 · BWF
Trudell Medical International
Anesthesiology · 238d
Cleared Aug 17, 2018
Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck...
K180574 · ONB
J & J Solutions, Inc. D/B/A/ Corvida...
General Hospital · 165d
Cleared Aug 17, 2018
Watch-PAT300
K180775 · MNR
Itamar Medical , Ltd.
Anesthesiology · 147d
Cleared Aug 17, 2018
BioWaveGO
K180943 · GZJ
Biowave Corporation
Neurology · 129d
Cleared Aug 17, 2018
CBit Series Digital Color Doppler Ultrasound System
K180974 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 126d
Cleared Aug 17, 2018
Simple Science Antimicrobial Facial and Eyelid Cleanser
K181074 · FRO
Simple Science, LLC
General & Plastic Surgery · 115d
Cleared Aug 17, 2018
Actifuse Flow
K181306 · MQV
Baxter Healthcare Corporation
Orthopedic · 92d
Cleared Aug 17, 2018
Ultraxx Nephrostomy Balloon Catheter Set
K181713 · LJE
Cook Incorporated
Gastroenterology & Urology · 50d
Cleared Aug 17, 2018
Cios Select
K181767 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Aug 17, 2018
Quantum Workstation 12.1
K181923 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 30d
Cleared Aug 17, 2018
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
K181940 · OXC
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 29d