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: 2026–2026 ×
1,642 results
529–552 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Not Cleared May 08, 2026
Modius Spero
DEN250013 · SHX
Neurovalens Limited
Neurology · 387d
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
Cleared May 06, 2026
Polyethylene
K260775 · GAT
Teleflex Medical, LLC
General & Plastic Surgery · 57d
Cleared May 06, 2026
YP-710T Series NIBP Cuff
K260747 · DXQ
Nihon Kohden Corporation
Cardiovascular · 61d
Cleared May 06, 2026
Denture Base
K260376 · EBI
Shandong Huge Dental Material...
Dental · 90d
Cleared May 06, 2026
KardiaPSI Balloon Catheter
K253855 · OZT
Intervention Tech, Inc. ; dba Corvention
Cardiovascular · 154d
Cleared May 06, 2026
BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)
K253152 · DXN
Biozen, LLC
Cardiovascular · 222d
Cleared May 06, 2026
Anchor with Fiber Wire and Disposable Inserter
K253027 · MBI
Ortobio S.A.
Orthopedic · 229d
Cleared May 06, 2026
Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
K252552 · KPI
Shenzhen Changkun Technology Co., Ltd.
Gastroenterology & Urology · 266d