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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13729–13752 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 2022
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360...
K220109 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 47d
Cleared Feb 28, 2022
ENFit enteral syringes (NUTRIFIT)
K211661 · PNR
Pentaferte Italia S.R.L.
Gastroenterology & Urology · 272d
Cleared Feb 28, 2022
Disposable Nitrile Examination Gloves
K212833 · LZA
Chifeng Huawei Medical...
General Hospital · 174d
Cleared Feb 28, 2022
Vathin Video Bronchoscope System
K213635 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 103d
Cleared Feb 28, 2022
VyLink™ Spinal Screw System
K213750 · NKB
Vy Spine, LLC
Orthopedic · 90d
Cleared Feb 26, 2022
CardioChek Plus Test System
K193406 · NBW
Polymer Technology Systems, Inc....
Chemistry · 810d
Cleared Feb 25, 2022
Masimo SedLine Sedation Monitor and Accessories
K203113 · OLW
Masimo Corporation
Anesthesiology · 498d
Cleared Feb 25, 2022
Cool-tip RF Ablation System E Series
K203150 · GEI
Covidien, LLC
General & Plastic Surgery · 491d
Cleared Feb 25, 2022
Okamoto 002 Lubricated Polyurethane Male Condom
K203541 · MOL
Okamoto USA, Inc.
Obstetrics & Gynecology · 449d
Cleared Feb 25, 2022
OmniTom Elite
K211711 · JAK
Neurologica Corporation, A Subsidiary...
Radiology · 267d
Cleared Feb 25, 2022
Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares
K211722 · GEX
Canadian Pioneer Medical Technology...
General & Plastic Surgery · 266d
Cleared Feb 25, 2022
Ion Facet Screw System
K211855 · MRW
SurGenTec, LLC
Orthopedic · 254d
Cleared Feb 25, 2022
Pulse Oximeter
K212300 · DQA
Shenzhen Mericonn Technology Co., Ltd.
Anesthesiology · 218d
Cleared Feb 25, 2022
PRIMA Humeral System and SMR Glenosphere Ø42
K212800 · PHX
Lima Corporate S.P.A.
Orthopedic · 176d
Cleared Feb 25, 2022
Levator Elite (Model LE9011)
K213043 · IPF
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 156d
Cleared Feb 25, 2022
Ear Thermometer, Model ET005, ET008, ET009
K213084 · FLL
Guangzhou Berrcom Medical Device Co.,...
General Hospital · 155d
Cleared Feb 25, 2022
VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole...
K213241 · LON
bioMerieux, Inc.
Microbiology · 148d
Cleared Feb 25, 2022
MAGNETOM Vida with syngo MR XA50A
K213693 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 94d
Cleared Feb 25, 2022
FEops HEARTguide
K214066 · QQI
Feops NV
Cardiovascular · 60d
Cleared Feb 25, 2022
Explorer Air II
K214097 · IZI
Surgvision GmbH
General & Plastic Surgery · 59d
Cleared Feb 25, 2022
Normatec 3
K220217 · IRP
NormaTec Industries, LP
Physical Medicine · 30d
Cleared Feb 25, 2022
Cohitech Cottonlock Tampons with Reusable Applicator
K220238 · HEB
Cotton High Tech S.L.
Obstetrics & Gynecology · 28d
Cleared Feb 24, 2022
Bodygard SFS Surgical Gown Level 3
K202845 · FYA
Feliks Plastik Laminasyon VE Ambalaj...
General Hospital · 517d
Cleared Feb 24, 2022
PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing
K210135 · FRO
3M Healthcare Business Group
General & Plastic Surgery · 401d