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
985–1008 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Mar 20, 2026
SOMATOM X.cite
K253574 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 123d
Cleared Mar 20, 2026
Photonova Spectra, Photonova Spectra Select
K253520 · JAK
Ge Medical Systems, LLC
Radiology · 128d
Cleared Mar 20, 2026
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
K253098 · OBP
Nexstim Oyj
Neurology · 178d
Cleared Mar 20, 2026
Bifix Veneer LC, Bifix Veneer Try-In
K252606 · EMA
Voco GmbH
Dental · 214d
Cleared Mar 20, 2026
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
K252358 · OBP
Nexstim Oyj
Neurology · 234d
Cleared Mar 20, 2026
Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
K252050 · EOB
Olympus Medical Systems Corporation
Ear, Nose, Throat · 262d
Cleared Mar 20, 2026
Arthrex Humeral Nails
K252016 · HSB
Arthrex, Inc.
Orthopedic · 266d
Cleared Mar 20, 2026
Livi Device
K252005 · HEB
Liviwell, Inc.
Obstetrics & Gynecology · 266d
Cleared Mar 20, 2026
ClaveQS™ Bag
K251980 · KPE
Icu Medical, Inc.
General Hospital · 266d
Cleared Mar 20, 2026
Endobronchial Blocker Tube (EBT0109)
K251950 · CBI
Hangzhou Tappa Medical Technology...
Anesthesiology · 268d
Cleared Mar 20, 2026
nordicAudio (1.0)
K251937 · LNH
Nordicneurolab AS
Radiology · 269d
Cleared Mar 19, 2026
Willow 24 Guidewire
K260537 · MOF
Arbor Endovascular, LLC
Neurology · 30d
Cleared Mar 19, 2026
ELISIO™-H
K260533 · KDI
Nipro Medical Corporation
Gastroenterology & Urology · 30d
Cleared Mar 19, 2026
Derma-Gide
K260532 · KGN
Geistlich Pharma AG
General & Plastic Surgery · 30d
Cleared Mar 19, 2026
AutoContour (RADAC V5)
K260509 · QKB
Radformation, Inc.
Radiology · 30d
Cleared Mar 19, 2026
CastleLoc Pectus Bar System
K260448 · HRS
L & K Biomed Co., Ltd.
Orthopedic · 36d
Cleared Mar 19, 2026
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic)...
K254269 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 79d
Cleared Mar 19, 2026
Dia-X Sil Bite
K254112 · ELW
DiaDent Group International
Dental · 90d
Cleared Mar 19, 2026
CureLight Medical Diode Laser Systems (CureLight F2-A15
K253965 · ILY
Wuhan PHOMED Technology Company , Ltd.
General & Plastic Surgery · 98d
Cleared Mar 19, 2026
Enroute 0.014'' Transcarotid Guidewire
K253746 · DQX
Lake Region Medical
Cardiovascular · 114d
Cleared Mar 19, 2026
DiversiVy™ Facet Screw System
K253432 · MRW
Vy Spine, LLC
Orthopedic · 169d
Cleared Mar 19, 2026
Disposable Distal Cap
K253139 · FBN
Mirco-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 175d
Cleared Mar 19, 2026
JWG-1
K252101 · ITI
Yamaha Motor Co., Ltd.
Physical Medicine · 259d
Cleared Mar 18, 2026
APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)
K260830 · LBH
Sangi Co, Ltd.
Dental · 5d