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
15673–15696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 2021
Lunit INSIGHT MMG
K211678 · QDQ
Lunit, Inc.
Radiology · 169d
Cleared Nov 17, 2021
Promisemed Sharps container
K211890 · MMK
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 149d
Cleared Nov 17, 2021
Soteria.AI
K212336 · OWB
Omega Medical Imaging, LLC
Radiology · 113d
Cleared Nov 17, 2021
Arthrex Modular Glenoid System-Titanium Glenosphere
K212415 · PHX
Arthrex, Inc.
Orthopedic · 106d
Cleared Nov 17, 2021
Qora Stool Management Kit
K212444 · KNT
Cm Technologies, Inc.
Gastroenterology & Urology · 104d
Cleared Nov 17, 2021
Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
K212456 · LNH
Hyperfine, Inc.
Radiology · 104d
Cleared Nov 17, 2021
BruxZir Esthetic
K213425 · EIH
Prismatik Dentalcraft, Inc.
Dental · 27d
Cleared Nov 16, 2021
Enteral Feeding Set
K210854 · PIF
Kb Medical (Group), Inc.
Gastroenterology & Urology · 238d
Cleared Nov 16, 2021
Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
K211286 · CAH
Pall Corporation
General Hospital · 203d
Cleared Nov 16, 2021
Esperance Aspiration Catheter System
K211697 · NRY
Wallaby Medical
Neurology · 166d
Cleared Nov 16, 2021
Deploy Expandable Interbody System
K211845 · MAX
Southern Spine, LLC
Orthopedic · 154d
Cleared Nov 16, 2021
Disposable Medical Nitrile Examination Gloves (non-sterile)
K212029 · LZA
Taizhou Kangjian Medical Equipments...
General Hospital · 140d
Cleared CT Nov 16, 2021
Pantheris System
K212047 · MCW
Avinger, Inc.
Cardiovascular · 139d
Cleared Nov 16, 2021
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound...
K212265 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 119d
Cleared Nov 16, 2021
Surgical Mask
K212344 · FXX
Xiantao Dingcheng Non-Woven Product...
General Hospital · 111d
Cleared Nov 16, 2021
InZone Detachment System
K212455 · HCG
Stryker Neurovascular
Neurology · 103d
Cleared Nov 16, 2021
Opulent TiNbN Coated Knee
K212839 · JWH
Meril Healthcare Pvt. , Ltd.
Orthopedic · 70d
Cleared Nov 16, 2021
Sterile PHALINX Hammertoe System
K212996 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 57d
Cleared Nov 16, 2021
MOTOTM Partial Knee & MOTO PFJ Systems Extension
K213071 · HSX
Medacta International S.A.
Orthopedic · 54d
Cleared Nov 15, 2021
Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe...
K211329 · MEG
Jiangsu Kangbao Medical Equipment...
General Hospital · 196d
Cleared Nov 15, 2021
SofWave System
K211483 · OHV
Sofwave Medical, Ltd.
General & Plastic Surgery · 187d
Cleared Nov 15, 2021
Vital Signs Monitor
K211754 · MWI
Beijing Choice Electronic Technology...
Cardiovascular · 161d
Cleared Nov 15, 2021
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
K212301 · LFL
Covidien, LLC
General & Plastic Surgery · 115d
Cleared Nov 15, 2021
Darwin
K212607 · GEX
Luvo Medical Technologies, Inc.
General & Plastic Surgery · 90d