FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
793–816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 2026
aprevo® anterior and lateral lumbar interbody system
K260385 · MAX
Carlsmed, Inc.
Orthopedic · 92d
Cleared May 08, 2026
AerFrame Patient Immobilization System (AFPIS)
K260792 · IYE
Stabilix, LLC
Radiology · 58d
Cleared May 08, 2026
Smylio Aligners
K260788 · NXC
Smylio, Inc.
Dental · 59d
Cleared May 08, 2026
LingOral Dental Design System
K260419 · PNN
Hangzhou ChohoTech Co., Ltd.
Dental · 88d
Cleared May 08, 2026
HipGuide (V 1.0.0.0)
K260321 · LLZ
Orthopedic Driven Imaging, LLC
Radiology · 98d
Cleared May 08, 2026
Arthrex Beaming System
K254215 · HWC
Arthrex, Inc.
Orthopedic · 130d
Cleared May 08, 2026
Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
K253991 · HSB
Orthofix Srl
Orthopedic · 147d
Cleared May 08, 2026
Hydro Irrigation System
K253679 · GWG
Stryker Instruments
Neurology · 168d
Cleared May 08, 2026
AYON Body Contouring System™ (AYON SYSTEM)
K253396 · QPB
Apyx Medical Corporation
General & Plastic Surgery · 220d
Cleared May 08, 2026
Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
K253237 · GXY
Elde Medikal Sanayi ve Ticaret Anonim...
Neurology · 221d
Cleared May 08, 2026
Disposable Stone Retrieval Balloon Catheter
K253013 · GCA
Zhejiang Soudon Medical Technology...
Gastroenterology & Urology · 231d
Cleared May 08, 2026
DeepSkin (DEP100)
K252621 · NFO
El Global Trade, Ltd.
Neurology · 262d
Cleared May 08, 2026
MiroCam® Capsule Endoscope System
K252617 · NEZ
Intromedic Co., Ltd.
Gastroenterology & Urology · 262d
Cleared May 08, 2026
Alegria Flash SSA-60
K250814 · OBE
Zeus Scientific
Immunology · 417d
Cleared May 07, 2026
CO2 Laser Machine (Monica-I,Monica-II)
K260974 · GEX
Nanjing Bestview Laser S&T Co., Ltd.
General & Plastic Surgery · 44d
Cleared May 07, 2026
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue
K260460 · NHA
Institut Straumann AG
Dental · 85d
Cleared May 07, 2026
Lynx Aspiration Catheter System
K254276 · NRY
Q'Apel Medical, Inc.
Neurology · 128d
Cleared May 07, 2026
MR Conditional Cup Electrodes
K254183 · GXY
Technomed Europe
Neurology · 135d
Cleared May 07, 2026
Veritas Reverse Total Shoulder System
K253992 · PHX
Restor3d
Orthopedic · 146d
Cleared May 07, 2026
SPECTRALIS HRA+OCT and variants
K253837 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 157d
Cleared May 07, 2026
Aliya® EX System
K253826 · OAB
Galvanize Therapeutics, Inc.
General & Plastic Surgery · 157d
Cleared May 07, 2026
SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System,...
K253739 · NKB
Globus Medical, Inc.
Orthopedic · 164d
Cleared May 07, 2026
Evita (V800)
K253647 · CBK
Draegerwerk AG & CO Kgaa
Anesthesiology · 168d
Cleared May 06, 2026
CastleLoc-P Anterior Cervical Plate System
K261112 · KWQ
L & K Biomed Co., Ltd.
Orthopedic · 33d