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: Cleared only ×
174,955 results
1177–1200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 2026
MESI mTABLET SPIRO
K251777 · BZG
Mesi D.O.O.
Anesthesiology · 265d
Cleared Feb 27, 2026
HOTWIRE RF GUIDEWIRE (901XXX)
K260292 · DXF
Atraverse Medical
Cardiovascular · 29d
Cleared Feb 27, 2026
HKT Anatomical Locking Trauma System
K254249 · HRS
Hankil Tech Medical Co., Ltd.
Orthopedic · 60d
Cleared Feb 27, 2026
Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)
K253829 · GEX
Beijing HuaCheng Taike Technology...
General & Plastic Surgery · 88d
Cleared Feb 27, 2026
Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)
K253828 · GEX
Beijing HuaCheng Taike Technology...
General & Plastic Surgery · 88d
Cleared Feb 27, 2026
One-Stop
K253797 · MVL
Mediclus Co., Ltd.
Dental · 91d
Cleared Feb 27, 2026
Allday Moisturizing Rinse
K253778 · LFD
Elevate Oral Care
Dental · 93d
Cleared Feb 27, 2026
LigaMend
K253695 · MBI
Riverpoint Medical, LLC
Orthopedic · 98d
Cleared Feb 27, 2026
Evala Nerve Stimulator (EPNR002)
K253536 · ETN
Epineuron Technologies, Inc.
Ear, Nose, Throat · 106d
Cleared Feb 27, 2026
Ligence Heart
K253535 · QIH
Ligence Uab
Radiology · 106d
Cleared Feb 27, 2026
C-Lant Port
K252714 · GCJ
Vigor Medical Technologies , Ltd.
General & Plastic Surgery · 184d
Cleared Feb 27, 2026
AViTA Pulse Oximeter (SP61)
K252448 · DQA
Avita Corporation
Anesthesiology · 207d
Cleared Feb 27, 2026
Atellica CH Diazo Total Bilirubin (D_TBil)
K251998 · CIG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 245d
Cleared Feb 26, 2026
Enbio PRO
K260254 · FLE
Enbio Group AG
General Hospital · 30d
Cleared Feb 26, 2026
CAPRI
K254271 · GEX
ORO Co., Ltd.
General & Plastic Surgery · 58d
Cleared Feb 26, 2026
InnovexView (GC146-17, GC150-20, GC155-23)
K254251 · HIH
Shanghai AnQing Medical Instrument...
Obstetrics & Gynecology · 59d
Cleared Feb 26, 2026
KARL STORZ ICG Imaging System with RUBINA® Lens
K254242 · OWN
Karl Storz SE & CO. KG
General & Plastic Surgery · 59d
Cleared Feb 26, 2026
Aster
K254182 · KWQ
Osteonic Co., Ltd.
Orthopedic · 65d
Cleared Feb 26, 2026
SWINGO-3D Lumbar Cage System
K254017 · MAX
Implanet
Orthopedic · 73d
Cleared Feb 26, 2026
PUREVUE™ Quick Connect Cannula System Tray
K253791 · KCT
DePuy Mitek, Inc.
General Hospital · 90d
Cleared Feb 26, 2026
ENOS Software Guided External Fixation System
K253764 · OSN
Disior, Ltd.
Orthopedic · 93d
Cleared Feb 26, 2026
Owl Night Guard
K253641 · OBR
Owl Dental Lab, Inc.
Dental · 99d
Cleared Feb 26, 2026
BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax
K253578 · QAS
Aidoc Medical , Ltd.
Radiology · 101d
Cleared Feb 26, 2026
GMK 3D Metal Tibial Tray Extension
K253328 · MBH
Medacta International S.A.
Orthopedic · 149d