Search FDA 510(k) Devices

5,400 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
457–480 of 3,225
Cleared Nov 07, 2025
Primeprint Direct Aligner
K250739 · NXC
Dreve Dentamid GmbH
Dental · 241d
Cleared Nov 07, 2025
SugarBug (1.x)
K250264 · MYN
Bench7, Inc.
Radiology · 282d
Cleared Nov 07, 2025
Triathlon Pro
K243131 · NUH
Sigma Biomedical
Neurology · 403d
Cleared Nov 06, 2025
Motive™ Muscle Stimulator for Lower Back (OT01-1003)
K253478 · NGX
Motive Health, Inc.
Physical Medicine · 23d
Cleared Nov 06, 2025
BriefCase-Triage
K253265 · QAS
Aidoc Medical , Ltd.
Radiology · 38d
Cleared Nov 06, 2025
Tandem Mobi insulin pump with interoperable technology
K253074 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 44d
Cleared Nov 06, 2025
Venus Nova (FP-2001)
K252845 · GEI
Venus Concept, Inc.
General & Plastic Surgery · 59d
Cleared Nov 06, 2025
AIO Breathe
K252525 · LRK
Aiomega, LLC
Dental · 87d
Cleared Nov 06, 2025
Q-Switched Nd:Yag laser (K690)
K252515 · GEX
Hebei Keylaser Sci-Tech Co.,Ltd
General & Plastic Surgery · 87d
Cleared Nov 06, 2025
MAGNABOND SE
K252469 · KLE
Dmp Dental Industry S.A.
Dental · 92d
Cleared Nov 06, 2025
Catalyst F1x Shoulder System
K252418 · KWS
Catalyst Orthoscience, Inc.
Orthopedic · 97d
Cleared Nov 06, 2025
Adaptix Ortho350
K252133 · IZF
Adaptix Limited
Radiology · 122d
Cleared Nov 06, 2025
Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)
K251792 · DXX
Stereotaxis, Inc.
Cardiovascular · 148d
Cleared Nov 06, 2025
Ultra™ Compression Screw System
K251555 · HWC
Pace Surgical
Orthopedic · 169d
Cleared Nov 06, 2025
Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
K251004 · OXO
Hefei Chimed Intelligent Machine Co.,...
Radiology · 219d
Cleared Nov 06, 2025
Hubly Drill (H100)
K250815 · HBE
Hubly, Inc.
Neurology · 234d
Cleared Nov 06, 2025
mb-FIX Cranial Stabilization Systems
K250423 · HBL
Medical Bees GmbH
Neurology · 265d
Cleared Nov 05, 2025
Polyshield Safety IV Catheters
K252677 · FOZ
Poly Medicure Limited
General Hospital · 72d
Cleared Nov 05, 2025
EVAC-MRI
K252514 · JXG
Phasor Health, LLC
Neurology · 86d
Cleared Nov 05, 2025
ExcelsiusGPS™ Instruments
K250599 · OLO
Globus Medical, Inc.
Orthopedic · 250d
Cleared Nov 05, 2025
ViVY
K250376 · IMJ
Viatherm Therapeutics, LLC
Physical Medicine · 268d
Cleared Nov 05, 2025
Allure Hip Stem and Intramedullary Plugs
K250375 · MEH
Waldemar Link GmbH & Co. KG
Orthopedic · 268d
Cleared Nov 05, 2025
Depth Electrode (RSDE-08)
K250363 · GZL
Beijing Sinovation Medical Technology...
Neurology · 268d
Cleared Nov 04, 2025
PRIMED Surgical and Procedure Masks
K252964 · FXX
Primed Medical Products, Inc.
General Hospital · 48d