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
10081–10104 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2023
c1Trac
K222912 · ITH
Zimmer Medizinsysteme GmbH
Physical Medicine · 232d
Cleared May 16, 2023
Insufflator
K222812 · HIF
Scivita Medical Technology Co., Ltd.
Obstetrics & Gynecology · 239d
Cleared May 16, 2023
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
K222736 · QOF
Hologic, Inc.
Microbiology · 249d
Cleared May 16, 2023
BlueCheck™ Caries Detection & Monitoring
K222560 · LFC
Incisive Technologies Pty, Ltd.
Dental · 265d
Cleared May 16, 2023
Gunther Tulip Vena Cava Filter Retrieval Set
K222254 · MMX
Cook Incorporated
Cardiovascular · 293d
Cleared May 16, 2023
Babylog VN800, Babylog VN600
K222207 · CBK
Draegerwerk AG & CO Kgaa
Anesthesiology · 295d
Cleared May 16, 2023
Evita V800, Evita V600
K222024 · CBK
Draegerwerk AG & CO Kgaa
Anesthesiology · 309d
Cleared May 16, 2023
VERSAJET Hydrosurgery System (III)
K220964 · FQH
Smith & Nephew Medical Limited
General & Plastic Surgery · 410d
Cleared May 15, 2023
Combi Touch
K231391 · ELC
Mectron S.P.A.
Dental · 3d
Cleared May 15, 2023
Dexcom G7 Continuous Glucose Monitoring (CGM) System
K231081 · QBJ
Dexcom, Inc.
Chemistry · 28d
Cleared May 15, 2023
Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs...
K230121 · LZA
Careglove Global Sdn. Bhd.
General Hospital · 118d
Cleared May 15, 2023
Vathin® Video Bronchoscope System
K223836 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 144d
Cleared May 15, 2023
Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
K222836 · NHA
Institut Straumann AG
Dental · 237d
Cleared May 15, 2023
HD+12, HD+15
K220526 · DRG
Cardioline S.P.A
Cardiovascular · 445d
Cleared May 15, 2023
Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro)
K202993 · PHW
Mmj Labs, LLC
Physical Medicine · 957d
Cleared May 14, 2023
myLEDmask
K223147 · OHS
Myblend
General & Plastic Surgery · 221d
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 13, 2023
HEATING TENS/EMS, FT-810R
K223308 · NUH
Hivox Biotek, Inc.
Neurology · 197d
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 12, 2023
EPIQ Series Diagnostic Ultrasound System
K231190 · IYN
Philips Ultrasound, LLC
Radiology · 16d
Cleared May 12, 2023
SOMAVAC® 100 Sustained Vacuum System
K231063 · BTA
Somavac Medical Solutions, Inc.
General & Plastic Surgery · 28d
Cleared May 12, 2023
Ahmed® Glaucoma Valve Model FP8
K231051 · KYF
New World Medical, Inc.
Ophthalmic · 29d
Cleared May 12, 2023
Ahmed® Glaucoma Valve Model FP7
K230975 · KYF
New World Medical, Inc.
Ophthalmic · 37d
Cleared May 12, 2023
RadiForce MX217
K230684 · PGY
Eizo Corporation
Radiology · 60d