FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
5497–5520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 19, 2024
XENOVIEW 3.0T Chest Coil
K243316 · MOS
Polarean, Inc.
Radiology · 28d
Cleared Nov 19, 2024
Freedom® Medial Congruent Liner
K243277 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 34d
Cleared Nov 19, 2024
“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
K243045 · JAQ
Braxx Biotech Co., Ltd.
Radiology · 53d
Cleared Nov 19, 2024
Natus BrainWatch System
K242930 · OMC
Natus Medical Incorporated Dba...
Neurology · 56d
Cleared Nov 19, 2024
ACUSON Sequoia Diagnostic Ultrasound System
K242523 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Nov 19, 2024
EUROPA™ Posterior Cervical Fusion System
K242516 · NKG
MiRus, LLC
Orthopedic · 88d
Cleared Nov 19, 2024
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)
K242496 · IYO
Eieling Technology (Shenzhen) Limited
Radiology · 89d
Cleared Nov 19, 2024
Medical Thulium Fiber Laser Systems (UroFiber 60Q)
K242293 · GEX
Rhein Laser Technologies Co., Ltd.
General & Plastic Surgery · 109d
Cleared Nov 19, 2024
CerroZone Mini
K242102 · FRF
Cerrozone, LLC
General Hospital · 124d
Cleared Nov 19, 2024
Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)
K242028 · BTA
Dongguanshi Yiyingmei Technology Co.,...
Ear, Nose, Throat · 131d
Cleared Nov 19, 2024
Nova Allegro UACR Assay, Nova Allegro Analyzer
K221813 · CGX
Nova Biomedical Corporation
Chemistry · 881d
Cleared Nov 19, 2024
XPER Technology PREMIUM Pro Blood Glucose Monitoring System
K221349 · PZI
Taidoc Technology Corporation
Chemistry · 925d
Cleared Nov 18, 2024
Montage-XT Settable Bone Putty
K243506 · MQV
Orthocon, Inc.
Orthopedic · 6d
Cleared Nov 18, 2024
Air Pressure Therapy System (VU-IPC04B)
K243320 · IRP
Xiamen Weiyou Intelligent Technology...
Physical Medicine · 26d
Cleared Nov 18, 2024
Power Wheelchair (W5538)
K242471 · ITI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 90d
Cleared Nov 18, 2024
Power wheelchair
K242402 · ITI
Zhejiang Zhonglei Medical Technology...
Physical Medicine · 97d
Cleared Nov 18, 2024
CT Collaboration Live
K242329 · LLZ
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 104d
Cleared Nov 18, 2024
MICRO Arterial Filters
K242092 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 124d
Cleared Nov 18, 2024
da Vinci SP Instruments (SP1098)
K241814 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 147d
Cleared Nov 18, 2024
Saige-Dx
K241747 · QDQ
DeepHealth, Inc.
Radiology · 153d
Cleared Nov 18, 2024
Tenex 2nd Generation System
K241700 · LFL
Trice Medical, Inc.
General & Plastic Surgery · 158d
Cleared Nov 18, 2024
Informed Vital Core Application (IVC App)
K241633 · QME
Mindset Medical, Inc.
Cardiovascular · 165d
Cleared Nov 18, 2024
Diode laser Treatment System (K18)
K241498 · GEX
Hebei Keylaser Sci-Tech Co.,Ltd
General & Plastic Surgery · 174d
Cleared Nov 18, 2024
Synxess Neurovascular Guidewire
K240871 · MOF
Enlight Medical Technologies...
Neurology · 234d