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
12721–12744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 2022
AXIR-CX
K213520 · LLZ
Radisen Co., Ltd.
Radiology · 289d
Cleared Aug 19, 2022
Lexa PLUS RIS-311
K213758 · FLE
W&H Sterilization S.R.L.
General Hospital · 262d
Cleared Aug 19, 2022
Percent Oxygen Sensors
K213933 · CCL
Careox, LLC
Anesthesiology · 246d
Cleared Aug 19, 2022
Viramed Borrela All-In-One ViraChip Test Kit
K220016 · LSR
Viramed Biotech AG
Microbiology · 226d
Cleared Aug 19, 2022
BD MAX Enteric Parasite Panel
K220193 · PCH
Becton, Dickinson and Company
Microbiology · 207d
Cleared Aug 19, 2022
Disposable Endoscope Injection Needle
K220292 · FBK
Yangzhou Fartley Medical Instrument...
Gastroenterology & Urology · 199d
Cleared Aug 19, 2022
SmartAdjust(TM) technology
K220394 · QJI
Insulet Corporation
Chemistry · 189d
Cleared Aug 19, 2022
uCerv Flux-C 3D Porous Titanium Cervical Interbody
K220696 · ODP
Ulrich Medical USA
Orthopedic · 163d
Cleared Aug 19, 2022
DynaClip® Bone Staple
K220812 · JDR
MedShape, Inc.
Orthopedic · 151d
Cleared Aug 19, 2022
Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman...
K221023 · PEK
Spinal Simplicity, LLC
Orthopedic · 135d
Cleared Aug 19, 2022
REAL INTELLIGENCE CORI
K221224 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 113d
Cleared Aug 19, 2022
FUJIFILM Ultrasonic Endoscope EG-740UT
K221238 · ODG
Fujifilm Corporation
Gastroenterology & Urology · 112d
Cleared Aug 19, 2022
Cortera Spinal Fixation System
K221403 · NKB
Surgalign Spine Technologies
Orthopedic · 95d
Cleared Aug 19, 2022
OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33),...
K221824 · OCX
Cipher Surgical Limited
Gastroenterology & Urology · 57d
Cleared Aug 19, 2022
prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments
K221848 · QLQ
Centinel Spine, LLC
Orthopedic · 56d
Cleared Aug 19, 2022
Stent Positioning Assistance System (SPAS)
K221917 · DQX
Seven Sons , Ltd.
Cardiovascular · 50d
Cleared Aug 19, 2022
1688 4K Camera System with Advanced Imaging Modality
K222130 · GCJ
Stryker
General & Plastic Surgery · 32d
Cleared Aug 19, 2022
MI View&GO
K222172 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Aug 19, 2022
Baby Gorilla®/Gorilla® Plating System
K222194 · HRS
Paragon 28, Inc.
Orthopedic · 28d
Cleared Aug 19, 2022
SmartBolus Calculator
K222239 · QRX
Insulet Corporation
Chemistry · 24d
Cleared Aug 18, 2022
Bio-MEM Ti Reinforced Membrane
K210797 · NPK
B&Medi Co., Ltd.
Dental · 520d
Cleared Aug 18, 2022
Jeesung Safety Syringe and Single Use Needles
K212518 · MEG
Jeesung Medical Co., Ltd.
General Hospital · 373d
Cleared Aug 18, 2022
iClean Viral Transport System (VTM-RT kit)
K212856 · JSM
Huachenyang (Shenzhen) Technology Co....
Microbiology · 344d
Cleared Aug 18, 2022
Sotair Device
K212905 · BTM
Safe Bvm Corporation
Anesthesiology · 339d