FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
16993–17016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 2021
Fist Assist Devices Model FA-1
K210281 · IRP
Fist Assist Devices, LLC
Physical Medicine · 136d
Cleared Jun 17, 2021
Migraine Tens Digital Pain Reliever
K210364 · PCC
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 129d
Cleared Jun 17, 2021
NaviNetics D1 Stereotactic System
K210700 · HAW
Navinetics, Inc.
Neurology · 100d
Cleared Jun 17, 2021
aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler...
K210883 · EOQ
Ambu A/S
Ear, Nose, Throat · 84d
Cleared Jun 17, 2021
MIS Lance+ Conical Connection Dental Implant System
K210886 · DZE
Dentsply Sirona
Dental · 84d
Cleared Jun 17, 2021
Sonata Transcervical Fibroid Ablation System 2.2
K211535 · KNF
Gynesonics, Inc.
Obstetrics & Gynecology · 30d
Cleared Jun 16, 2021
Aptiva Celiac Disease IgA Reagent
K193604 · MVM
Inova Diagnostics, Inc.
Immunology · 541d
Cleared Jun 16, 2021
Qmenta Care Platform Family
K202718 · LLZ
Mint Labs, Inc., D/B/A. Qmenta
Radiology · 272d
Cleared Jun 16, 2021
Disposable Medical Surgical Face Mask
K203200 · FXX
Guangdong Haiou Medical Apparatus...
General Hospital · 230d
Cleared Jun 16, 2021
EnsoSleep
K210034 · OLZ
Ensodata, Inc.
Neurology · 161d
Cleared Jun 16, 2021
Silent Nite Sleep Appliance with the Glidewell Hinge
K210694 · LRK
Prismatik Dentalcraft, Inc.
Dental · 100d
Cleared Jun 16, 2021
iBOT Personal Mobility Device (iBOT PMD)
K210920 · IMK
Mobius Mobility
Physical Medicine · 79d
Cleared Jun 16, 2021
Sublime Radial Access 018 RX Dilatation Catheter
K211044 · LIT
Creagh Medical Ltd. (A Wholly Owned...
Cardiovascular · 69d
Cleared Jun 16, 2021
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black,...
K211310 · LZA
Megine Industries Sdn Bhd
General Hospital · 47d
Cleared Jun 16, 2021
Disposable Vinyl Examination Glove
K211336 · LYZ
Inner Mongolia Cureguard Medical...
General Hospital · 44d
Cleared Jun 15, 2021
CellChek 20 rc
K203244 · NFJ
Konan Medical, Inc.
Ophthalmic · 224d
Cleared Jun 15, 2021
SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers
K210595 · MAX
Camber Spine Technologies, LLC
Orthopedic · 106d
Cleared Jun 15, 2021
Amerishield Surgical Mask
K211520 · FXX
Premiumestore, LLC
General Hospital · 29d
Cleared Jun 14, 2021
Manual Wheelchair (Model W28)
K200466 · IOR
Jiangsu Jumao X-Care Medical...
Physical Medicine · 474d
Cleared Jun 14, 2021
Ultrasonic Mesh Nebulizer
K201397 · CAF
Shenzhen Ivankaca Technology Co., Ltd.
Anesthesiology · 382d
Cleared Jun 14, 2021
URO-TOUCH 9 French Probe
K202813 · FFK
Northgate Technologies, Inc.
Gastroenterology & Urology · 263d
Cleared Jun 14, 2021
Corrugated tube with mouthpiece accessory
K203400 · CAF
Trudell Medical International
Anesthesiology · 207d
Cleared Jun 14, 2021
CATS®-D Tonometer Prism
K203850 · HKY
Cats Tonometer, LLC
Ophthalmic · 165d
Cleared Jun 14, 2021
Surgical Face Mask
K210518 · FXX
Shandong Haidike Medical Products...
General Hospital · 111d