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
6073–6096 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 2024
SUPER VELOCE
K241699 · GEX
Ilooda Co,., Ltd.
General & Plastic Surgery · 61d
Cleared Aug 13, 2024
Power wheelchair (N6101)
K241686 · ITI
Zhejiang Zhonglei Medical Technology...
Physical Medicine · 62d
Cleared Aug 13, 2024
Diode Laser Therapy Device (DF-DIODE LASER-S1)
K241547 · GEX
Weifang Dragonfly Electronics...
General & Plastic Surgery · 74d
Cleared Aug 13, 2024
ECHELON Synergy MRI System
K241429 · LNH
Fujifilm Healthcare Corporation
Radiology · 84d
Cleared Aug 13, 2024
CoLink NeoFuse MIS Plating System (see attached parts list)
K241387 · HRS
In2bones USA
Orthopedic · 90d
Cleared Aug 13, 2024
Bullsai
K241094 · LLZ
Turing Medical Technologies, Inc.
Radiology · 113d
Cleared Aug 13, 2024
VM-2000
K240807 · CBK
Ventis Medical, Inc.
Anesthesiology · 141d
Cleared Aug 12, 2024
dS FootAnkle Coil 8ch 1.5T
K242096 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 25d
Cleared Aug 12, 2024
OptimMRI (v2)
K242054 · QIH
Rebrain, Sas
Radiology · 28d
Cleared Aug 12, 2024
E3D™-C Interbody System
K241846 · OVE
Evolution Spine
Orthopedic · 47d
Cleared Aug 12, 2024
Eneka Selectif
K241656 · GEX
Termosalud
General & Plastic Surgery · 63d
Cleared Aug 12, 2024
Medical Monitor (32HR734S)
K241402 · GCJ
Lg Electronics.Inc
General & Plastic Surgery · 87d
Cleared Aug 12, 2024
Pixie Pulse (SM9068)
K241365 · NUH
Pixie Cup, LLC
Neurology · 90d
Cleared Aug 12, 2024
aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF)
K241328 · MAX
Carlsmed, Inc.
Orthopedic · 94d
Cleared Aug 12, 2024
Ultravision2™ IonPencil
K240868 · PQM
Alesi Surgical Limited
General Hospital · 136d
Cleared Aug 12, 2024
iDart Lyme IgG ImmunoBlot Kit
K233367 · LSR
Id-Fish Technology, Inc.
Microbiology · 315d
Cleared Aug 09, 2024
EnSite™ X EP System
K242016 · DQK
Abbott Medical
Cardiovascular · 30d
Cleared Aug 09, 2024
HyperSuture All Blue Extension Line
K241376 · GAT
Threadstone, LLC
General & Plastic Surgery · 86d
Cleared Aug 09, 2024
ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
K240664 · KNW
SurGenTec, LLC
General & Plastic Surgery · 154d
Cleared Aug 09, 2024
Access TPO Antibody
K240469 · JZO
Beckman Coulter, Inc.
Immunology · 171d
Cleared Aug 09, 2024
Electric Wheelchair (Panda 10)
K240079 · ITI
Suzhou Ideal Medical Co., Ltd.
Physical Medicine · 211d
Cleared Aug 09, 2024
F&P Optiflow Flow Diverter
K234053 · CBP
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 231d
Cleared Aug 09, 2024
SonoMax Series Digital Color Doppler Ultrasound System
K233697 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 266d
Cleared Aug 09, 2024
F&P Airvo 3 NIV (PT311US)
K233643 · MNT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 270d