Search FDA 510(k) Devices

5,431 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
1321–1344 of 174,061
Cleared Oct 24, 2025
AccuCheck
K250696 · IYE
Manteia Technologies Co., Ltd.
Radiology · 231d
Cleared Oct 24, 2025
Cocoon Solo (DX-7020s)
K250687 · MUH
Dexcowin Global, Inc.
Radiology · 232d
Cleared Oct 24, 2025
Medline Bag Decanter
K250345 · LHI
Medline Industries, LP
General Hospital · 260d
Cleared Oct 23, 2025
UV5000W Handle
K253226 · FAJ
Uroviu Corporation
Gastroenterology & Urology · 24d
Cleared Oct 23, 2025
MultiPulse TFL
K253100 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 29d
Cleared Oct 23, 2025
Invisalign® Palatal Expander System
K252931 · NXC
Align Technology, Inc.
Dental · 38d
Cleared Oct 23, 2025
1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)
K252732 · GEX
Zhengzhou PZ Laser Slim Technology...
General & Plastic Surgery · 56d
Cleared Oct 23, 2025
Silatrix Oral Gel
K252425 · OLR
Sa3, LLC
Dental · 83d
Cleared Oct 23, 2025
DESS® Dental Smart Solutions
K252384 · NHA
Terrats Medical SL
Dental · 84d
Cleared Oct 23, 2025
Picosecond Laser Device (PF131-BI)
K252345 · GEX
Risu Medical Technology Co., Ltd.
General & Plastic Surgery · 87d
Cleared Oct 23, 2025
PerQseal Introducers
K252309 · DYB
Vivasure Medical Limited
Cardiovascular · 91d
Cleared Oct 23, 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs,...
K250861 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 216d
Cleared Oct 23, 2025
TeraRecon Cardiovascular.Calcification.CT
K250288 · QIH
Terarecon,Inc.
Radiology · 265d
Cleared Oct 22, 2025
FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone...
K253147 · MQV
Prosidyan, Inc.
Orthopedic · 27d
Cleared Oct 22, 2025
Pre-Sutured Tendon
K253145 · GAT
Rti Surgical, Inc.
Orthopedic · 27d
Cleared Oct 22, 2025
Freedom® Total Knee System – Titan PCK Components
K253144 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 27d
Cleared Oct 22, 2025
Carrier XL Delivery Catheter
K252569 · QJP
Balt USA, LLC
Neurology · 69d
Cleared Oct 22, 2025
QIAstat-Dx Gastrointestinal Panel 2
K252329 · PCH
QIAGEN GmbH
Microbiology · 89d
Cleared Oct 22, 2025
Hair Growth Laser Cap
K252325 · OAP
Cosmo Far East Technology Limited
General & Plastic Surgery · 89d
Cleared Oct 22, 2025
SIros-X System
K252322 · OUR
Genesys Spine
Orthopedic · 89d
Cleared Oct 22, 2025
ANDI 2.0
K252298 · QIH
Imeka Solutions, Inc.
Radiology · 91d
Cleared Oct 22, 2025
electric breast pump (FZ-P8)
K251977 · HGX
Ningbo Youhe Electrical Appliance...
Obstetrics & Gynecology · 117d
Cleared Oct 22, 2025
Flowflex Plus RSV + Flu A/B + COVID Home Test
K251749 · SCA
ACON Laboratories, Inc.
Microbiology · 138d
Cleared Oct 22, 2025
Giraffe OmniBed Carestation (CS1)
K251663 · FMZ
Datex-Ohmeda, Inc.
General Hospital · 145d