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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
14065–14088 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 2022
iASSIST Knee System
K213033 · OLO
Orthosoft D/B/A Zimmer Cas
Orthopedic · 115d
Cleared Jan 14, 2022
Eclipse II with Smart Noise Cancellation
K213307 · MQB
Carestream Health, Inc.
Radiology · 102d
Cleared Jan 14, 2022
Capsule Surveillance System
K213335 · MWI
Capsule Surveillance Technologies,...
Cardiovascular · 100d
Cleared Jan 14, 2022
OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
K213593 · OBJ
Boston Scientific Corporation
Cardiovascular · 63d
Cleared Jan 14, 2022
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis...
K213602 · FJS
Covidien, LLC
Gastroenterology & Urology · 60d
Cleared Jan 14, 2022
UltraPrint-Dental Temp C&B UV
K213643 · EBG
Guangzhou Heygears IMC., Inc.
Dental · 57d
Cleared Jan 14, 2022
Quantib ND
K213737 · LLZ
Quantib B.V.
Radiology · 46d
Cleared Jan 14, 2022
SCOPE BUDDY PLUS Endoscope Flushing Aid
K213833 · FEB
Medivators, Inc.
General Hospital · 36d
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