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
2089–2112 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 04, 2025
Voyant® Open Fusion Device (EB240/Open Fusion)
K252740 · GEI
Applied Medical Resources Corp.
General & Plastic Surgery · 68d
Cleared Nov 04, 2025
GMReis Suture Anchors
K252664 · MBI
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 74d
Cleared Nov 04, 2025
MedCAD® AccuStride™ System
K251709 · PBF
Medcad
Orthopedic · 154d
Cleared Nov 04, 2025
VXvue
K251410 · LLZ
Vieworks Co., Ltd.
Radiology · 181d
Cleared Nov 04, 2025
Tamburo Thulium Fiber Laser System
K251303 · GEX
Menovex Medical Technology (Shenzhen)...
General & Plastic Surgery · 190d
Cleared Nov 04, 2025
Merit Syringe
K250853 · FMF
Merit Medical Systems, Inc.
General Hospital · 228d
Cleared Nov 04, 2025
Flexx Junior (FLX-J00, FLX-J50)
K250576 · IOR
Karma Mobility Co, Ltd.
Physical Medicine · 250d
Cleared Nov 04, 2025
Cios Select
K250241 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 281d