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
745–768 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Apr 15, 2026
Midas Restore
K260661
Sprintray, Inc.
Dental · 44d
Cleared Apr 15, 2026
Diode Laser Therapy Systems (V19)
K260307 · GEX
Weifang Mingliang Electronics Co., Ltd.
General & Plastic Surgery · 75d
Cleared Apr 15, 2026
VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance
K260282 · LON
bioMerieux, Inc.
Microbiology · 76d
Cleared Apr 15, 2026
Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )
K260129 · OLI
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 89d
Cleared Apr 15, 2026
BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes
K260128 · JKA
Becton, Dickinson and Company
Chemistry · 89d
Cleared Apr 15, 2026
Refobacin Bone Cement R (110034355)
K254107 · LOD
Biomet France
Orthopedic · 117d
Cleared Apr 15, 2026
ASTar BC G- Kit
K253573 · SAN
Q-Linea AB
Microbiology · 149d
Cleared Apr 15, 2026
REGEN Bioactive Cement
K253337 · EMA
Inter-Med, Inc.
Dental · 197d
Cleared Apr 15, 2026
STERRAD 100NX Sterilization System with ALLClear Technology (10104)
K252843 · MLR
Advanced Sterilization Products, Inc.
General Hospital · 219d
Cleared Apr 15, 2026
Uni-C Cervical Cage System
K252774 · OVE
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 225d
Cleared Apr 15, 2026
IDS-iSYS Total Testosterone
K252728 · CDZ
Immunodiagnostic Systems Limited
Chemistry · 230d
Cleared Apr 15, 2026
Comprehensive Reverse Shoulder - HA Glenosphere Baseplates
K252404 · PHX
Biomet Orthopedics
Orthopedic · 258d
Cleared Apr 15, 2026
VERIQA RT EPID 3D
K252258 · IYE
Ptw-Freiburg...
Radiology · 268d
Cleared Apr 14, 2026
Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
K260931 · DQA
Unimed Medical Supplies, Inc.
Anesthesiology · 25d
Cleared Apr 14, 2026
Equinoxe® Shoulder System
K260583 · PHX
Exactech, Inc.
Orthopedic · 53d
Cleared Apr 14, 2026
TriMemo™ SEMIRIGID ANNULOPLASTY RING
K260498 · KRH
Corcym S.r.l.
Cardiovascular · 60d
Cleared Apr 14, 2026
Critical Care Suite with Enteric Tube Positioning AI Algorithm
K253502 · QIH
Ge Medical Systems, LLC
Radiology · 166d
Cleared Apr 14, 2026
Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
K253107 · BTA
Shenzhen Dongjiang Technology Co., Ltd.
Ear, Nose, Throat · 202d
Cleared Apr 14, 2026
Inbentus Versatile
K252663 · CBK
Iconic Solutions by Murcia, SL
Anesthesiology · 235d
Cleared Apr 14, 2026
HD 8Ch Wrist Array
K252587 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 242d
Cleared Apr 13, 2026
CVAC Aspiration System
K260965 · FED
Calyxo, Inc.
Gastroenterology & Urology · 21d
Cleared Apr 13, 2026
HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK...
K260340 · ODP
HC Biologics, LLC
Orthopedic · 70d
Cleared Apr 13, 2026
Heal-Check Rapid COVID-19 Antigen Self-Test
K260095 · QYT
Healgen Scientific, LLC
Microbiology · 90d
Cleared Apr 13, 2026
Aventus Introducer Sheath
K260091 · DYB
Inquis Medical
Cardiovascular · 91d