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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
9049–9072 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 2023
IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012,...
K231717 · OHT
Foshan Jindi Electric Appliance Co.,...
General & Plastic Surgery · 85d
Cleared Sep 06, 2023
IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
K230824 · LPL
Art Optical Contact Lens, Inc.
Ophthalmic · 166d
Cleared Sep 06, 2023
Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic...
K230127 · FGE
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 232d
Cleared Sep 06, 2023
HI-EMT MAGSHAPE
K230024 · NGX
Beijing Sano Laser S&T Development...
Physical Medicine · 245d
Cleared Sep 06, 2023
Phoenix ICON, Phoenix ICON GO
K223575 · HKI
Neolight, LLC
Ophthalmic · 280d
Cleared Sep 05, 2023
Polibond
K232691 · EBI
Zirkonzahn Srl
Dental · 4d
Cleared Sep 05, 2023
Promaxo MRI System II
K232361 · LNH
Promaxo, Inc.
Radiology · 29d
Cleared Sep 05, 2023
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
K231819 · HWC
Innovate Orthopaedics Limited
Orthopedic · 76d
Cleared Sep 05, 2023
ICHOR 14F Embolectomy System
K230743 · QEW
Ichor
Cardiovascular · 173d
Cleared Sep 05, 2023
F&P 820 Humidification System
K223684 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 271d
Cleared Sep 05, 2023
BCR-ABL1 (p210) % IS Kit (Digital PCR Method)
K221869 · OYX
Suzhou Sniper Medical Technologies...
Medical Genetics · 434d
Cleared Sep 05, 2023
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
K221197 · CEW
Ortho-Clinical Diagnostics
Chemistry · 498d
Cleared Sep 05, 2023
Ki Power Tilt System
K201869 · ITI
Ki Mobility, LLC
Physical Medicine · 1155d
Cleared Sep 05, 2023
Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL
K200583 · IOR
Ki Mobility, LLC
Physical Medicine · 1278d
Cleared Sep 01, 2023
InnerView LC
K232657 · EKX
Perimetrics, Inc.
Dental · 1d
Cleared Sep 01, 2023
Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor
K232340 · MBI
Arthrex, Inc.
Orthopedic · 28d
Cleared Sep 01, 2023
DEKA SIMON
K232334 · IPF
El.En S.P.A.
Physical Medicine · 28d
Cleared Sep 01, 2023
Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)
K232314 · FDS
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 30d
Cleared Sep 01, 2023
HyperLight Portable X-ray Unit
K232068 · EHD
Changzhou Sifary Medical Technology...
Radiology · 51d
Cleared Sep 01, 2023
Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
K232021 · MOS
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 56d
Cleared Sep 01, 2023
CONDUIT™ ATP Inserters
K232014 · MAX
Enztec Limited
Orthopedic · 57d
Cleared Sep 01, 2023
TRIOCLEAR System
K231884 · NXC
Modern Dental Laboratory (Dg) Co., Ltd.
Dental · 66d
Cleared Sep 01, 2023
OW100S
K231710 · PZL
Softwave/Trt, LLC
General & Plastic Surgery · 81d
Cleared Sep 01, 2023
Montage Flowable Settable, Resorbable Bone Paste
K231270 · MQV
Orthocon, Inc.
Orthopedic · 122d