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
15169–15192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 2022
Respiratory Gating for Scanners v2.0
K213927 · JAK
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Jan 13, 2022
Dental Electric Motor
K203706 · EBW
Guilin Woodpecker Medical Instrument...
Dental · 391d
Cleared Jan 13, 2022
3N Contact Lenses Adjunct Cleaner
K211361 · LYL
Suzhou 3N Biological Technology Co.,...
Ophthalmic · 255d
Cleared Jan 13, 2022
Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
K213642 · IYN
Ge Healthcare
Radiology · 56d
Cleared Jan 13, 2022
Stronghold Group Nitrile Examination Glove, Powder Free
K213859 · LZA
Stronghold Group, LLC
General Hospital · 34d
Cleared Jan 13, 2022
Distal Humerus Plating System
K213895 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 30d
Cleared Jan 13, 2022
PRESIDENT The Original
K220097 · ELW
Colt?ne/Whaledent AG
Dental · 1d
Cleared Jan 12, 2022
UNiD Spine Analyzer
K212005 · LLZ
Medicrea International, Inc.
Radiology · 198d
Cleared Jan 12, 2022
Materialise Shoulder System™, Materialise Shoulder Guide and Models,...
K212569 · QHE
Materialise NV
Orthopedic · 149d
Cleared Jan 12, 2022
Surgical gowns
K212718 · FYA
Xiantao Dingcheng Non-Woven Product...
General Hospital · 138d
Cleared Jan 12, 2022
Arm Blood Pressure Monitor
K212877 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 125d
Cleared Jan 12, 2022
andorate Suction Valve, andorate Air/Water Valve
K213095 · ODC
Ga Health Company Limited
Gastroenterology & Urology · 110d
Cleared Jan 12, 2022
Venus BlissMAX
K213308 · PBX
Venus Concept USA, Inc.
Physical Medicine · 100d
Cleared Jan 12, 2022
BIB Stent Placement Catheter
K213915 · NVM
NuMED, Inc.
Cardiovascular · 28d
Cleared Jan 12, 2022
Straight Arm DDR
K214012 · KPR
Konica Minolta Healthcare Americas, Inc.
Radiology · 21d
Cleared Jan 11, 2022
i3 Foldable Mobility Scooter
K191356 · INI
Puc Perfect Union Co., Ltd.
Physical Medicine · 966d
Cleared Jan 11, 2022
Cardiovascular Suite 4.2.1
K202094 · DQK
Quipu S.R.L
Cardiovascular · 532d
Cleared Jan 11, 2022
Ora-Aid
K211851 · OLR
Tbm Corporation
General & Plastic Surgery · 210d
Cleared Jan 11, 2022
Disposable Surgical Gown
K212591 · FYA
Suzhou Janee Medical Technology Co.,...
General Hospital · 148d
Cleared Jan 11, 2022
Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)
K212735 · LZA
Xingyu Medical Tech Co., Ltd.
General Hospital · 134d
Cleared Jan 11, 2022
ES1 System
K213102 · IYN
E-Scopics
Radiology · 109d
Cleared Jan 11, 2022
Medical Examination Gloves
K213168 · LZA
Shandong Huiwosheng Health Technology...
General Hospital · 105d
Cleared Jan 11, 2022
Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System
K213199 · HWC
Stryker GmbH
Orthopedic · 104d
Cleared Jan 11, 2022
360CAS
K213380 · OLO
Kico Knee Innovation Company Pty Limited
Orthopedic · 90d