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: 2026–2026 ×
1,922 results
1825–1848 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jan 15, 2026
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
K251308 · LBI
Thera B Medical Products
General Hospital · 262d
Cleared Jan 15, 2026
Ignite RF System
K251254 · GEI
Inmode , Ltd.
General & Plastic Surgery · 267d
Not Cleared Jan 15, 2026
VitaSmart Hypothermic Oxygenated Perfusion System
DEN250009 · SGY
Bridge TO Life, Ltd.
Gastroenterology & Urology · 290d
Cleared Jan 14, 2026
dS Base 1.5T
K254190 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 22d
Cleared Jan 14, 2026
ExacTrac Dynamic (2.0.2)
K254010 · IYE
Brainlab SE
Radiology · 30d
Cleared Jan 14, 2026
SmartGuard technology
K253585 · QJI
Medtronic Minimed, Inc.
Chemistry · 58d
Cleared Jan 14, 2026
Concerto Versa™ Detachable Coil
K253511 · KRD
Medtronic, Inc.
Cardiovascular · 70d
Cleared Jan 14, 2026
METICULY Patient-specific titanium mesh implant
K252958 · GXN
Meticuly Co., Ltd.
Neurology · 120d
Cleared Jan 14, 2026
Orthoscan TAU MVP Mini C-Arm System
K252579 · OXO
Ziehm-Orthoscan, Inc.
Radiology · 152d
Cleared Jan 14, 2026
Cardinal Health Nitrile Examination Gloves Extended Cuff
K252313 · LZC
Cardinalhealth
General Hospital · 173d
Cleared Jan 14, 2026
Cervical Interbody and VBR Fusion System
K252219 · ODP
Sync Surgical
Orthopedic · 183d
Cleared Jan 14, 2026
ENTire IRE System
K251996 · GEI
Entire Medical , Ltd.
General & Plastic Surgery · 201d
Cleared Jan 14, 2026
Laboratorios Biogalenic Sterile Water for Inhalation, USP
K251419 · BTT
Laboratorios Biogalenic S.A. DE C.V.
Anesthesiology · 252d
Cleared Jan 13, 2026
Connected OR Hub with Device and Voice Control
K254014 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 29d
Cleared Jan 13, 2026
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364)
K254001 · KPS
Spectrum Dynamics Medical, Ltd.
Radiology · 29d
Cleared Jan 13, 2026
Bright Cavity Liner
K253248 · EJK
Dmp Dental Industry S.A.
Dental · 106d
Cleared Jan 13, 2026
Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green),...
K252549 · LZA
Kossan International Sdn Bhd
General Hospital · 153d
Cleared Jan 13, 2026
Swedge™ Pedicle Screw Fixation System Bezier Rod
K252461 · NKB
Spinal Resources, Inc.
Orthopedic · 161d
Cleared Jan 13, 2026
BEAR® (Bridge-Enhanced ACL Restoration) Implant
K251214 · QNI
Miach Orthopaedics, Inc.
Orthopedic · 270d
Cleared Jan 12, 2026
Any-Paste
K253167 · KIF
Mediclus Co., Ltd.
Dental · 108d
Cleared Jan 12, 2026
DYNAMIS™ Navigation System
K252962 · OLO
Promethean Restorative, LLC
Orthopedic · 118d
Cleared Jan 12, 2026
Break Wave
K252913 · LNS
Sonomotion, Inc.
Gastroenterology & Urology · 122d
Cleared Jan 12, 2026
Disposable Surgical Face Mask (3P00B, C2900)
K252830 · FXX
Beatles Medical Supplies (Xiantao)...
General Hospital · 129d
Cleared Jan 12, 2026
Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates
K252807 · HRS
Arthrex, Inc.
Orthopedic · 131d