FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
11569–11592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 2023
Provata Implant System
K222457 · DZE
Southern Implants (Pty), Ltd.
Dental · 203d
Cleared Mar 06, 2023
LC ChromeFlow
K222445 · EBF
S&C Polymer Silicon- Und Composite...
Dental · 203d
Cleared Mar 06, 2023
Pro-X1™ Trochanteric Nailing System
K221621 · HSB
X-Bolt Orthopedics
Orthopedic · 276d
Cleared Mar 06, 2023
Single-Use Video Flexible Ureterorenoscope System
K221158 · FGB
Guangzhou Red Pine Medical Instrument...
Gastroenterology & Urology · 319d
Cleared Mar 06, 2023
Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories
K212161 · MWI
Masimo Corporation
Anesthesiology · 602d
Cleared Mar 05, 2023
Nitronox Scavenger Plus
K223452 · CBN
Parker Hannifin Corporation
Anesthesiology · 110d
Cleared Mar 03, 2023
CoverScan (CoverScan v1.1)
K230294 · LLZ
Perspectum
Radiology · 29d
Cleared Mar 03, 2023
Rebellion, Phantom Multi-Bite Kerrison Rongeur
K230256 · HAE
Morpheus AG
Neurology · 31d
Cleared Mar 03, 2023
Lyra Influenza A+B Assay
K230236 · OZE
Quidel Corporation
Microbiology · 32d
Cleared Mar 03, 2023
Light Based Hair Removal Device GP592
K230060 · OHT
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 53d
Cleared Mar 03, 2023
EZ Bond Universal
K230009 · KLE
Meta Biomed Co., Ltd.
Dental · 59d
Cleared Mar 03, 2023
PEEK Spinal Infusion Cage
K223776 · MAX
Changzhou Geasure Medical Apparatus...
Orthopedic · 77d
Cleared Mar 03, 2023
Grappler Suture Anchor R3FLEX IOL System
K223589 · MBI
Paragon 28, Inc.
Orthopedic · 92d
Cleared Mar 03, 2023
Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)
K222880 · KNT
Endolumik, Inc.
Gastroenterology & Urology · 162d
Cleared Mar 03, 2023
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
K222819 · JAK
Canon Medical Systems Corporation
Radiology · 165d
Cleared Mar 03, 2023
imani i2Plus Breast Pump
K222573 · HGX
Imani Co.
Obstetrics & Gynecology · 190d
Cleared Mar 03, 2023
FreeStyle Libre 2 Flash Glucose Monitoring System
K222447 · QBJ
Abbott Diabetes Care, Inc.
Chemistry · 200d
Cleared Mar 03, 2023
Electronic Sphygmomanometers
K222394 · DXN
Qingdao Yasee Medical Device Co., Ltd.
Cardiovascular · 207d
Cleared Mar 03, 2023
Alinity m STI Assay
K222379 · QEP
Abbott Molecular, Inc.
Microbiology · 210d
Cleared Mar 03, 2023
Polypectomy Snare
K221713 · FDI
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 263d
Cleared Mar 03, 2023
INJECTION PIN (KIP(02031-02061) (03031-03061))
K221697 · NDN
Slk Ortho, LLC
Orthopedic · 266d
Cleared Mar 03, 2023
Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)
K221661 · DXC
Compression Works, Inc.
Cardiovascular · 268d
Cleared Mar 03, 2023
NIKKICART
K221652 · KPO
Renal Care Dialysis Solutions, S.A....
Gastroenterology & Urology · 269d
Cleared Mar 03, 2023
DHX-70H, XTG-70H
K221587 · EHD
Digimed Co., Ltd.
Radiology · 275d