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
10369–10392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 2023
Dexcom G7 Continuous Glucose Monitoring (CGM) System
K231081 · QBJ
Dexcom, Inc.
Chemistry · 28d
Cleared May 15, 2023
Combi Touch
K231391 · ELC
Mectron S.P.A.
Dental · 3d
Cleared May 14, 2023
myLEDmask
K223147 · OHS
Myblend
General & Plastic Surgery · 221d
Cleared May 13, 2023
HEATING TENS/EMS, FT-810R
K223308 · NUH
Hivox Biotek, Inc.
Neurology · 197d
Cleared May 13, 2023
Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with...
K230217 · KGO
Grand Work Plastic Products Co., Ltd.
General Hospital · 107d
Cleared May 12, 2023
IU Implant System Abutment
K221969 · NHA
Warantec Co., Ltd.
Dental · 311d
Cleared May 12, 2023
Waypoint GPS
K222106 · QWP
Waypoint Orthopedics, Inc.
Neurology · 298d
Cleared May 12, 2023
Intraoperative Ultrasound Probe Cover
K222460 · ITX
Exact Medical Manufacturing
Radiology · 270d
Cleared May 12, 2023
Harvest Printable Resin
K222489 · EBI
Harvest Dental Products, LLC
Dental · 268d
Cleared May 12, 2023
iTFlow
K222854 · LLZ
Cardio Flow Design, Inc.
Radiology · 233d
Cleared May 12, 2023
BD Secondary Infusion Set
K223101 · FPA
Care Fusion
General Hospital · 224d
Cleared May 12, 2023
PMMA BLOCK
K223706 · EBG
Huliang(Shanghai) Bio-Tech Co., Ltd.
Dental · 151d
Cleared May 12, 2023
EUROSCREW NG
K230394 · MAI
Teknimed
Orthopedic · 87d
Cleared May 12, 2023
ClariVy™ Cervical IBF System
K230414 · ODP
Vy Spine, LLC
Orthopedic · 85d
Cleared May 12, 2023
RadiForce MX217
K230684 · PGY
Eizo Corporation
Radiology · 60d
Cleared May 12, 2023
Ahmed® Glaucoma Valve Model FP7
K230975 · KYF
New World Medical, Inc.
Ophthalmic · 37d
Cleared May 12, 2023
Ahmed® Glaucoma Valve Model FP8
K231051 · KYF
New World Medical, Inc.
Ophthalmic · 29d
Cleared May 12, 2023
SOMAVAC® 100 Sustained Vacuum System
K231063 · BTA
Somavac Medical Solutions, Inc.
General & Plastic Surgery · 28d
Cleared May 12, 2023
EPIQ Series Diagnostic Ultrasound System
K231190 · IYN
Philips Ultrasound, LLC
Radiology · 16d
Cleared May 12, 2023
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
K231224 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 14d
Cleared May 11, 2023
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL...
K220721 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 423d
Cleared May 11, 2023
Regeneten Bioinductive Implant
K222501 · OWY
Smith and Nephew, Inc.
Orthopedic · 266d
Cleared May 11, 2023
OpenTex
K222549 · NPK
Purgo Biologics, Inc.
Dental · 261d
Cleared May 11, 2023
CryoX Vitrification Freeze Kit / Thaw Kit
K223265 · MQL
Zhejiang Horizon Medical Technology...
Obstetrics & Gynecology · 199d