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
20977–21000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 2020
cortiQ PRO
K191432 · OLU
G.Tec Medical Engineering GmbH
Neurology · 240d
Cleared Jan 24, 2020
SYPMHONY™ OCT System
K192014 · NKG
Medos International SARL
Orthopedic · 179d
Cleared Jan 24, 2020
Blue Nitrile Examination Gloves Powder Free
K192333 · LZA
Jr Engineering & Medical Technologies...
General Hospital · 150d
Cleared Jan 24, 2020
BD Cathena (TM) Safety IV Catheter
K192493 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 135d
Cleared Jan 24, 2020
CMOS Video Esophagoscope SSU
K192523 · EOX
Karl Storz SE & CO. KG
Ear, Nose, Throat · 133d
Cleared Jan 24, 2020
Disposable SpO2 Sensor
K192608 · DQA
Shenzhen Sino-K Medical Technology...
Anesthesiology · 126d
Cleared Jan 24, 2020
Gemini Titan Sterilization Wrap
K192641 · FRG
Medline Industries, Inc.
General Hospital · 122d
Cleared Jan 24, 2020
CareSens S Clear BT Blood Glucose Monitoring System
K192859 · NBW
I-Sens, Inc.
Chemistry · 112d
Cleared Jan 24, 2020
APTUS Clavicle System
K192984 · HRS
Medartis AG
Orthopedic · 91d
Cleared Jan 24, 2020
MRCAT brain
K193109 · MUJ
Philips Medical Systems MR Finland
Radiology · 77d
Cleared Jan 24, 2020
Persona Personalized Knee System
K193223 · JWH
Zimmer, Inc.
Orthopedic · 63d
Cleared Jan 24, 2020
Stat Profile Prime Plus Analyzer System
K193246 · CHL
Nova Biomedical Corporation
Chemistry · 60d
Cleared Jan 24, 2020
FlightPlan for Embolization
K193261 · LLZ
GE Medical Systems SCS
Radiology · 59d
Cleared Jan 24, 2020
Reprocessed Achieve Catheter Connecting Cable
K193263 · NLH
Innovative Health, LLC
Cardiovascular · 59d
Cleared Jan 24, 2020
IQon Spectral CT
K193454 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 42d
Cleared Jan 23, 2020
VINNO 8, VINNO 6, VINNO 5
K190120 · IYN
Vinno Technology (Suzhou) Co.,Ltd
Radiology · 364d
Cleared Jan 23, 2020
FiteBac Cavity Cleanser
K190271 · LBH
Largent Health, LLC
Dental · 349d
Cleared Jan 23, 2020
GammaTile
K190839 · KXK
Gt Medical Technologies
Radiology · 297d
Cleared Jan 23, 2020
Elements Viewer
K191014 · LLZ
Brainlab AG
Radiology · 281d
Cleared Jan 23, 2020
Proneb Max
K191270 · CAF
Pari Respiratory Equipment, Inc.
Anesthesiology · 255d
Cleared Jan 23, 2020
Blue Phantom PT
K191821 · LHN
Iba Dosimetry GmbH
Radiology · 199d
Cleared Jan 23, 2020
STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader
K192025 · FRC
Advanced Sterilization Products (Asp)
General Hospital · 178d
Cleared Jan 23, 2020
Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535
K192092 · DXN
Seca GmbH & Co. KG
Cardiovascular · 171d
Cleared Jan 23, 2020
VistaScan USB Ultrasound Imaging System
K192170 · IYO
Emagine Solutions Technology, LLC
Radiology · 164d