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
17041–17064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 2021
Disposable Vinyl Examination Gloves
K210522 · LYZ
Shandong Shengshixincheng Medical...
General Hospital · 107d
Cleared Jun 10, 2021
Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9...
K210699 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 93d
Cleared Jun 10, 2021
Surgical Masks, Model:FE-1
K210767 · FXX
Hunan Triplex Precision Medical...
General Hospital · 87d
Cleared Jun 10, 2021
H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To...
K210972 · NUC
CC Wellness, LLC
Obstetrics & Gynecology · 71d
Cleared Jun 10, 2021
H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant,...
K210986 · NUC
CC Wellness, LLC
Obstetrics & Gynecology · 70d
Cleared Jun 10, 2021
BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular...
K211061 · QEY
Thrombolex, Inc.
Cardiovascular · 62d
Cleared Jun 10, 2021
syngo.via MI WorkFlows, Scenium, syngo MBF
K211459 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Jun 10, 2021
Callaly Tampliner
K211469 · HEB
Calla Lily Personal Care, Ltd.
Obstetrics & Gynecology · 30d
Cleared Jun 10, 2021
Fiducial Marker
K211590 · IYE
Carbon Medical Technologies, Inc.
Radiology · 17d
Cleared Jun 09, 2021
ELEOS Limb Salvage System with BioGrip
K203815 · JDI
Onkos Surgical
Orthopedic · 162d
Cleared Jun 09, 2021
Palm Bladder Scanner - PBSV7.1
K210591 · IYO
Mianyang Meike Electronic Equipment...
Radiology · 100d
Cleared Jun 09, 2021
Vivid S60N / Vivid S70N
K211216 · IYN
GE Medical Systems Ultrasound and...
Radiology · 47d
Cleared Jun 09, 2021
Navigated Anterolateral Disc Prep Instruments
K211441 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared Jun 09, 2021
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model...
K211490 · ERL
Stryker Corporation
Ear, Nose, Throat · 27d
Cleared Jun 08, 2021
Disposable Surgical Mask
K202126 · FXX
Shenzhen Peninsula Medical Co., Ltd.
General Hospital · 312d
Cleared Jun 08, 2021
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
K210458 · NQQ
Abbott Medical
Cardiovascular · 112d
Cleared Jun 08, 2021
Medical Face Mask
K211062 · FXX
Ammex-Weida (Hubei) Health and Safety...
General Hospital · 60d
Cleared Jun 08, 2021
ZOOM 71 Reperfusion Catheter
K211476 · NRY
Imperative Care, Inc.
Neurology · 27d
Cleared Jun 07, 2021
SnugKap
K193383 · MVA
Headstart, Ltd.
Neurology · 550d
Cleared Jun 07, 2021
HRVWatch-Mini Wrist Monitor
K201914 · DXN
Taiwan Scientific Corporation
Cardiovascular · 333d
Cleared Jun 07, 2021
Disposable Surgical Mask
K202580 · FXX
Qingdao Likangyuan Medical Device...
General Hospital · 272d
Cleared Jun 07, 2021
Suture Wing
K202663 · MBI
Osteonic Co., Ltd.
Orthopedic · 266d
Cleared Jun 07, 2021
X-Pac Expandable Lumbar Cage System
K203802 · MAX
Expanding Innovations, Inc.
Orthopedic · 161d
Cleared Jun 07, 2021
Augmented VaultLock Glenoid
K210050 · KWS
Arthrex, Inc.
Orthopedic · 150d