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
12553–12576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 2022
Ellusa Reusable Bipolar Cable
K222429 · GEI
Ellusa, LLC
General & Plastic Surgery · 29d
Cleared Sep 09, 2022
Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE...
K222440 · FRG
Steris
General Hospital · 28d
Cleared Sep 09, 2022
AMBARINO High-Class
K222723 · EBF
Creamed GmbH & Co. Produktions- Und...
Dental · 1d
Cleared Sep 08, 2022
MammaPrint FFPE NGS Kit
K210973 · NYI
Agendia, Inc.
Pathology · 526d
Cleared Sep 08, 2022
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light...
K211648 · DFH
Diazyme Laboratories, Inc.
Immunology · 468d
Cleared Sep 08, 2022
Dynamis Pro Family
K213267 · GEX
Fotona D.O.O.
General & Plastic Surgery · 343d
Cleared Sep 08, 2022
Ultrasonic Endo Activation Device (Model:Actor I pro)
K213947 · ELC
Changzhou Bomedent Medical Technology...
Dental · 265d
Cleared Sep 08, 2022
Cranial EM System
K213989 · HAW
Brainlab AG
Neurology · 262d
Cleared Sep 08, 2022
BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens
K220143 · LPL
Shenzhen Dashicheng Optical...
Ophthalmic · 233d
Cleared Sep 08, 2022
Soundly Anti Snoring Device
K220330 · LRK
Greystone Ip, Ltd.
Dental · 216d
Cleared Sep 08, 2022
NeoNavia Biopsy System
K220595 · KNW
Neodynamics AB
General & Plastic Surgery · 191d
Cleared Sep 08, 2022
Disposable Endoscope Valves System
K221331 · ODC
Changzhou Endoclean Medical Device...
Gastroenterology & Urology · 126d
Cleared Sep 08, 2022
Osstem Abutment System
K221684 · NHA
Osstem Implant Co., Ltd.
Dental · 90d
Cleared Sep 08, 2022
HD-550 Video Endoscope System
K222020 · NWB
Sonoscape Medical Corp.
Gastroenterology & Urology · 62d
Cleared Sep 08, 2022
EFAI ChestSuite XR Pleural Effusion Assessment System
K222076 · QFM
Ever Fortune.Ai, Co., Ltd.
Radiology · 56d
Cleared Sep 08, 2022
CAPTIVATE® Compression Screws
K222409 · HWC
Globus Medical, Inc.
Orthopedic · 29d
Cleared Sep 08, 2022
Ellusa Reusable Neutral Plates
K222425 · GEI
Ellusa, LLC
General & Plastic Surgery · 28d
Cleared Sep 07, 2022
EyeCTester
K203594 · QTW
Neuro-Eye Diagnostic Systems, LLC
Ophthalmic · 637d
Cleared Sep 07, 2022
AXIOS Stent and Electrocautery-Enhanced Delivery System
K220112 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 237d
Cleared Sep 07, 2022
Easi-Vue embolic microspheres System
K220567 · KRD
Abk Biomedical, Inc.
Cardiovascular · 191d
Cleared Sep 07, 2022
syngo.via RT Image Suite
K220783 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 174d
Cleared Sep 07, 2022
Matreneu Percutaneous Balloon Compression Kit
K220920 · HAO
Shenzhen Shineyard Medical Device Co....
Neurology · 161d
Cleared Sep 07, 2022
FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire,...
K221731 · MBI
T.A.G. Medical Products Corporation,...
Orthopedic · 84d
Cleared Sep 07, 2022
RightLance Blood Lancing System
K222034 · QRL
Beijing Ruicheng Medical Supplies...
General & Plastic Surgery · 58d