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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
15601–15624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 2021
6430 MyLabX75, 6430 MyLab XPro75
K212021 · IYN
Esaote, S.P.A.
Radiology · 80d
Cleared Sep 16, 2021
BioRoot Flow 0.5g, BioRoot Flow 2g
K212283 · KIF
Septodont
Dental · 57d
Cleared Sep 16, 2021
Symbia VA10A Family
K212604 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Sep 16, 2021
StrataMR II Valves and Shunts
K212641 · JXG
Medtronic Neurosurgery
Neurology · 27d
Cleared Sep 16, 2021
GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System...
K212742 · JWH
Waldemar Link GmbH & Co. KG
Orthopedic · 17d
Cleared Sep 15, 2021
RXS 1000
K202369 · MUH
Rolence Enterprise, Inc.
Radiology · 392d
Cleared Sep 15, 2021
GlucoSure HT Plus Blood Glucose Monitoring System
K202885 · NBW
Apex BioTechnology Corp.
Chemistry · 352d
Cleared Sep 15, 2021
Instrument tray, for semi-rigid ureteroscope
K203492 · KCT
Olympus Winter & Ibe GmbH
General Hospital · 300d
Cleared Sep 15, 2021
TruAbutment DS, TruBase
K203649 · NHA
Truabutment, Inc.
Dental · 275d
Cleared Sep 15, 2021
HealthCCSng
K210085 · JAK
Zebra Medical Vision, Ltd.
Radiology · 245d
Cleared Sep 15, 2021
INFRARED BODY THERMOMETER (Model: YK-001)
K210118 · FLL
Longnan Renzhong Medical Equipment...
General Hospital · 239d
Cleared Sep 15, 2021
TrueCare Biomedix Tamper Evident Cap
K210818 · FMF
Us Infusion Inc. D/B/A Truecare...
General Hospital · 181d
Cleared Sep 15, 2021
HTx Disposable Hysteroscope System
K211227 · HIH
Acuvu, Inc.
Obstetrics & Gynecology · 145d
Cleared Sep 15, 2021
Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters
K211276 · NLH
Innovative Health, LLC
Cardiovascular · 141d
Cleared Sep 15, 2021
Disposable Nitrile Gloves
K212009 · LZA
Jiangsu Shenglijie Safety Products...
General Hospital · 79d
Cleared Sep 15, 2021
mi-eye 3 needlescope with cannula, mi-tablet 3
K212556 · HRX
Trice Medical, Inc.
Orthopedic · 33d
Cleared Sep 15, 2021
BeamSite
K212606 · IYE
Doseoptics, LLC
Radiology · 29d
Cleared Sep 15, 2021
GLOBAL UNITE™ Platform Shoulder System
K212710 · PHX
Depuy Ireland UC
Orthopedic · 20d
Cleared Sep 14, 2021
LIAISON Ferritin
K193650 · DBF
DiaSorin, Inc.
Immunology · 624d
Cleared Sep 14, 2021
VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
K202396 · LON
bioMerieux, Inc.
Microbiology · 389d
Cleared Sep 14, 2021
Wilson Tech Disposable Medical Face Mask
K210184 · FXX
Wilson Tech (International) Limited
General Hospital · 232d
Cleared Sep 14, 2021
End Cap
K210461 · MSD
Medical Components Inc (Medcomp)
Gastroenterology & Urology · 210d
Cleared Sep 14, 2021
Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth...
K210586 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 200d
Cleared Sep 14, 2021
Compressible Limb and Circulation Therapy System, Model POWER-Q2300
K211283 · IRP
Wonjin Mulsan Co., Ltd.
Physical Medicine · 140d