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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: 2026–2026 ×
1,642 results
817–840 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Apr 08, 2026
CATAMARAN™ SI Joint Fusion System
K260477 · OUR
Tenon Medical
Orthopedic · 55d
Cleared Apr 08, 2026
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
K260420 · EOQ
MacroLux Medical Technology Co., Ltd.
Ear, Nose, Throat · 58d
Cleared Apr 08, 2026
Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)
K260197 · GCJ
Suzhou Shenyun Medical Equipment Co.,...
General & Plastic Surgery · 76d
Cleared Apr 08, 2026
TL-10 Laparoscopic Scope Cleaner
K260089 · GCJ
Scopix , Ltd.
General & Plastic Surgery · 86d
Cleared Apr 08, 2026
Wearable Breast Pump (Model S21A)
K260033 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 92d
Cleared Apr 08, 2026
Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D,...
K254258 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 100d
Cleared Apr 08, 2026
Pivot Insulin Delivery System
K253534 · LZG
Modular Medical
Chemistry · 146d
Cleared Apr 08, 2026
Profoject Enteral/Oral Feeding Syringe
K253268 · PNR
CMT Health PTE., Ltd.
Gastroenterology & Urology · 191d
Cleared Apr 08, 2026
Hemoclip
K252270 · PKL
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 261d
Cleared Apr 08, 2026
Apex Locator (FindPex)
K252224 · LQY
Changzhou Sifary Medical Technology...
Dental · 266d
Cleared Apr 08, 2026
myAir
K251889 · MNS
ResMed Corp
Anesthesiology · 292d
Cleared Apr 08, 2026
SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700
K251666 · MED
STERIS Corporation
General Hospital · 313d
Cleared Apr 07, 2026
AuST Steerable Sheath
K260942 · DYB
CenterPoint Systems, LLC
Cardiovascular · 18d
Cleared Apr 07, 2026
Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
K260860 · LYZ
Basic Medical Technology, Inc.
General Hospital · 22d
Cleared Apr 07, 2026
Multifunctional Operational Dissectors (Electrosurgical Pencils)
K260466 · GEI
Zhejiang shuyou Surgical Instrument...
General & Plastic Surgery · 54d
Cleared Apr 07, 2026
Elecsys Anti-HBc IgM
K260049 · SEI
Roche Diagnostics
Microbiology · 90d
Cleared Apr 07, 2026
Elecsys Anti-HAV IgM
K260048 · LOL
Roche Diagnostics
Microbiology · 90d
Cleared Apr 07, 2026
Elecsys Anti-HBc II
K260046 · SEI
Roche Diagnostics
Microbiology · 90d
Cleared Apr 07, 2026
IWD-Gel™
K254191 · FRO
InnovaCorium, Inc.
General & Plastic Surgery · 105d
Cleared Apr 07, 2026
Power Wheelchair (OS-R-M01S)
K253952 · ITI
Beijing OrionStar Technology Co., Ltd.
Physical Medicine · 118d
Cleared Apr 07, 2026
Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D,...
K253946 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 118d
Cleared Apr 07, 2026
PrimeSight UltraView System
K253905 · FAJ
Cogentix Medical, Inc.
Gastroenterology & Urology · 123d
Cleared Apr 07, 2026
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
K253801 · SHP
Anumana, Inc.
Cardiovascular · 130d
Cleared Apr 07, 2026
Voyager DSLT (430840610)
K252979 · HQF
Belkin Vision, Ltd.
Ophthalmic · 202d