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
9217–9240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 2023
Carnation series Diagnostic Ultrasound System
K230066 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 249d
Cleared Sep 15, 2023
i-STAT G3+ cartridge with the i-STAT 1 System
K223857 · CHL
Abbott Point of Care, Inc.
Chemistry · 266d
Cleared Sep 15, 2023
Sensis Vibe (VD15)
K223812 · DQK
Siemens Medical Solutions USA, Inc.
Cardiovascular · 269d
Cleared Sep 15, 2023
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource...
K223788 · FOZ
Medsource International, LLC
General Hospital · 270d
Cleared Sep 15, 2023
Elecsys Anti-Tg
K222610 · JZO
Roche Diagnostics
Immunology · 382d
Cleared Sep 15, 2023
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead...
K221860 · QNQ
Poonglim Pharmatech, Inc.
General Hospital · 445d
Cleared Sep 15, 2023
Access Thyroglobulin
K220972 · MSW
Beckman Coulter, Inc.
Immunology · 529d
Cleared Sep 15, 2023
Avologi Gel Primer (Model: Av25)
K220735 · GYB
Premier North America, Inc.
Neurology · 550d
Cleared Sep 14, 2023
LightForce Orthodontic System
K232827 · NJM
Lightforce Orthodontics
Dental · 1d
Cleared Sep 14, 2023
Provecta 3D Prime and Provecta 3D Prime Ceph
K232487 · OAS
Durr Dental SE
Radiology · 28d
Cleared Sep 14, 2023
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
K232467 · KDI
Baxter Healthcare Corporation
Gastroenterology & Urology · 30d
Cleared Sep 14, 2023
ThermPix Thermovisual Camera
K232462 · LHQ
Usa Therm, Inc.
Radiology · 30d
Cleared Sep 14, 2023
OrionXR
K232189 · LLZ
Hoth Intelligence, Inc.
Radiology · 52d
Cleared Sep 14, 2023
Anovo Pedestal
K232146 · QNM
Momentis Surgical , Ltd.
General & Plastic Surgery · 57d
Cleared Sep 14, 2023
IPL Hair Removal, Model: W-1095, W-1098
K232124 · OHT
Shenzhen Wochuan Electronic Co., Ltd.
General & Plastic Surgery · 59d
Cleared Sep 14, 2023
cNeuro cPET
K231576 · KPS
Combinostics OY
Radiology · 106d
Cleared Sep 14, 2023
PureWay 1.4 Quart Sharps Collector
K231484 · MMK
Pureway Compliance, Inc.
General Hospital · 114d
Cleared Sep 14, 2023
AccuCTP Pro
K231353 · LLZ
ArteryFlow Technology Co., Ltd.
Radiology · 127d
Cleared Sep 14, 2023
Hammerdesis™ Interphalangeal Fusion System
K231147 · HTY
Intelivation
Orthopedic · 146d
Cleared Sep 14, 2023
LW Retraction Cap
K231079 · NHA
Ossvis Co., Ltd.
Dental · 150d
Cleared Sep 14, 2023
Cove Putty, OsteoCove Putty
K231030 · MQV
SeaSpine Orthopedics Corporation
Orthopedic · 156d
Cleared Sep 14, 2023
FlowStar Analog Mixer Flowmeter
K230987 · BZR
Baldus Sedation GmbH & Co. KG
Anesthesiology · 161d
Cleared Sep 14, 2023
VitreJect® Needle
K230959 · FMI
Ocuject, LLC
General Hospital · 163d
Cleared Sep 14, 2023
SOFIA EX Intracranial Support Catheter
K230775 · QJP
MicroVention, Inc.
Neurology · 177d