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: 2026–2026 ×
1,922 results
1153–1176 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Apr 03, 2026
Hot and Cold Compression System (A02-C-032)
K252386 · IRP
Chengdu Cryo-Push Medical Technology...
Physical Medicine · 246d
Not Cleared Apr 03, 2026
neuropacs
DEN240071 · SHO
Automated Imaging Diagnostics, LLC
Neurology · 485d
Cleared Apr 02, 2026
Tahoe Unicondylar Knee System with TiNbN Overcoat
K260796 · HSX
Shalby Advanced Technologies, Inc....
Orthopedic · 22d
Cleared Apr 02, 2026
SPECCHIO
K260647 · PBX
El.En S.P.A.
General & Plastic Surgery · 34d
Cleared Apr 02, 2026
Onclarity™ Self-Collection Kit
K260184 · SEP
Becton, Dickinson and Company
Microbiology · 71d
Cleared Apr 02, 2026
Tina-quant Cardiac high sensitivity CRP III
K260026 · NQD
Roche Diagnostics
Chemistry · 87d
Cleared Apr 02, 2026
FLASH Flex™ Aorto-Ostial Angioplasty System
K254022 · LOX
Verge Medical, Inc.
Cardiovascular · 107d
Cleared Apr 02, 2026
Cryopush Cold Compression Device (A02-P-001)
K253076 · IRP
Chengdu Cryo-Push Medical Technology...
Physical Medicine · 191d
Cleared Apr 02, 2026
Wireless Probe Type Ultrasound Scanner
K252709 · IYN
Xuzhou Yongkang Electronic Science...
Radiology · 218d
Cleared Apr 02, 2026
Leforte MMF System
K252246 · JEY
Jeil Medical Corporation
Dental · 258d
Cleared Apr 02, 2026
BELLIGER ACE
K252229 · OWB
Genoray Co., Ltd.
Radiology · 260d
Cleared Apr 02, 2026
Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
K252198 · GEH
Medical Brands Laboratories B.V.
General & Plastic Surgery · 262d
Cleared Apr 02, 2026
BD Insyte™ IV Catheter
K252137 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 268d
Cleared Apr 02, 2026
LifeShield Infusion Safety Software Suite
K252130 · PHC
Icu Medical, Inc.
General Hospital · 269d
Cleared Apr 02, 2026
Disposable Infusion Bag for Parenteral Nutrition
K252079 · KPE
Beijing L&Z Medical Technology...
General Hospital · 274d
Cleared Apr 02, 2026
SMART M-CELL Bone Marrow Concentration System
K250518 · QBV
Miracell Co., Ltd.
Hematology · 405d
Cleared Apr 02, 2026
SMART M-CELL PRP Concentration System
K250516 · QBV
Miracell Co., Ltd.
Hematology · 405d
Cleared Apr 01, 2026
Arm Blood Pressure Monitor Models: ARM-30C+
K260276 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 62d
Cleared Apr 01, 2026
Hyaluronic Acid Vaginal Suppository (HA 5 mg)
K260007 · NUC
Hudi Pharma Srl
Obstetrics & Gynecology · 89d
Cleared Apr 01, 2026
Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL,...
K254225 · DXN
Shenzhen HanHan Technology Co., Ltd.
Cardiovascular · 93d
Cleared Apr 01, 2026
CoLumbo C-Spine
K254015 · QIH
Smart Soft Healthcare AD
Radiology · 107d
Cleared Apr 01, 2026
enHAnce PEEK Bunion System
K253718 · HRS
Nvision Biomedical Technologies, Inc.
Orthopedic · 128d
Cleared Apr 01, 2026
RM Electrode (RMH 25-01)
K253586 · HLZ
Retmap, Inc.
Ophthalmic · 135d
Cleared Apr 01, 2026
Medical Imaging Calibration Feature (MICF)
K253582 · SHN
Apple, Inc.
Radiology · 135d