Search FDA 510(k) Devices

5,404 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
913–936 of 174,061
Cleared Dec 15, 2025
Erchonia CLX (Model # CFL)
K252574 · OLI
Erchonia Corporation
General & Plastic Surgery · 123d
Cleared Dec 15, 2025
SleepRes PAP System
K251770 · BZD
Sleepres, Inc.
Anesthesiology · 188d
Cleared Dec 15, 2025
OptiMesh Multiplanar Expandable Interbody Fusion System
K251302 · OQB
Spineology, Inc.
Orthopedic · 231d
Cleared Dec 15, 2025
MFUSE (MS001)
K250319 · QSY
Machina Medical, Inc.
General & Plastic Surgery · 314d
Cleared Dec 14, 2025
Hypnos (369054-200)
K250851 · OLZ
Cadwell Industries, Inc.
Neurology · 268d
Cleared Dec 12, 2025
Affixus® Natural Nail® Proximal Humeral System
K253749 · HSB
Zimmer Switzerland Manufacturing GmbH
Orthopedic · 17d
Cleared Dec 12, 2025
TRAUMAGEL® 2.0 Hemostatic Gel
K253609 · QSY
Cresilon, Inc.
General & Plastic Surgery · 24d
Cleared Dec 12, 2025
Swoop® Portable MR Imaging® System
K253489 · LNH
Hyperfine, Inc.
Radiology · 49d
Cleared Dec 12, 2025
TopCEM Vigor SA Self-Adhesive Resin Cement
K252785 · EMA
Rizhao Huge Biomaterials Company, Ltd.
Dental · 101d
Cleared Dec 12, 2025
Halo Sterile Single-use Radial Fiber...
K252745 · GEX
Micro-Energy Medical Technology Co.,...
General & Plastic Surgery · 105d
Cleared Dec 12, 2025
EnCor EnCompass™ Breast Biopsy and Tissue Removal System
K252681 · KNW
Bard Peripheral Vascular, Inc.
General & Plastic Surgery · 109d
Cleared Dec 12, 2025
Revi System
K252391 · QXM
Bluewind Medical , Ltd.
Gastroenterology & Urology · 134d
Cleared Dec 12, 2025
Therapy US
K252273 · NHN
Dmc Importa??o E Exporta??o DE...
Physical Medicine · 143d
Cleared Dec 12, 2025
Fundus On Phone Non Mydriatic (FOP NM-10)
K252120 · HKI
Remidio Innovative Solutions Private...
Ophthalmic · 158d
Cleared Dec 12, 2025
Pterygoid Indication for GM Helix Implants
K252090 · DZE
JJGC Ind?stria e Com?rcio de...
Dental · 163d
Cleared Dec 12, 2025
VizMark Preloaded Tissue Marker Device (VM-0001)
K251989 · NEU
Breast-Med, Inc.
General & Plastic Surgery · 168d
Cleared Dec 12, 2025
Self-Seal Sterilization Pouch and Roll
K251177 · FRG
Guangdong Maidi Medical Co., Ltd.
General Hospital · 240d
Cleared Dec 12, 2025
iHealth Flu A&B/COVID-19 Rapid Test
K251092 · SCA
Ihealth Labs, Inc.
Microbiology · 246d
Cleared Dec 12, 2025
EXEL Disposable Syringe
K251089 · FMF
Exelint International, Co.
General Hospital · 246d
Cleared Dec 12, 2025
iHealth Flu A&B/COVID-19/RSV Rapid Test
K251085 · SCA
Ihealth Labs, Inc.
Microbiology · 247d
Cleared Dec 12, 2025
Bio Arterial Deluxe (IC-BAP-DX)
K250974 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 256d
Cleared Dec 12, 2025
FUJIFILM Ultrasonic Endoscope EB-710US
K250863 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 266d
Cleared Dec 12, 2025
VaporShield
K250847 · MEG
Vault Paragon Group, Inc.
General Hospital · 267d
Cleared Dec 12, 2025
Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon...
K250821 · DTZ
Eurosets S.R.L
Cardiovascular · 269d