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
3145–3168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 2025
eufy Wearable Breast Pump S1 (T8D02)
K250207 · HGX
Anker Innovations Limited
Obstetrics & Gynecology · 199d
Cleared Aug 11, 2025
Outlook Surgical Versa One System (8900139)
K241731 · EOB
Resnent, LLC
Ear, Nose, Throat · 420d
Cleared Aug 11, 2025
RW-1
K232456 · LLZ
Mediott, Inc.
Radiology · 728d
Cleared Aug 08, 2025
Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
K252176 · FAJ
Guangzhou Red Pine Medical Instrument...
Gastroenterology & Urology · 28d
Cleared Aug 08, 2025
OptiVu™ Shoulder
K252170 · SBF
Mr Surgical Solutions, LLC
Orthopedic · 29d
Cleared Aug 08, 2025
Diode laser device (BM091)
K251801 · GEX
Hebei Newangie Technology Co., Ltd.
General & Plastic Surgery · 57d
Cleared Aug 08, 2025
BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
K251713 · LON
Becton, Dickinson and Company
Microbiology · 66d
Cleared Aug 08, 2025
Aqua Medical RF Vapor Ablation System
K251226 · KNS
Aqua Medical, Inc.
Gastroenterology & Urology · 109d
Cleared Aug 08, 2025
MagVenture TMS Therapy System
K251119 · OBP
Tonica Elektronik A/S
Neurology · 119d
Cleared Aug 08, 2025
Coretech Compression System (Coretech RHB3003)
K250817 · JOW
Vive Health, LLC
Cardiovascular · 143d
Cleared Aug 08, 2025
swiftPro System (SWF-SPS)
K250718 · NEY
Emblation Limited
General & Plastic Surgery · 151d
Cleared Aug 08, 2025
SABER-C System
K250540 · OVE
Elevation Spine
Orthopedic · 165d
Cleared Aug 08, 2025
SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
K250472 · KTT
Amdt Holdings, Inc.
Orthopedic · 171d
Cleared Aug 08, 2025
Water-based Lubricant
K250142 · NUC
Global Protection Corp.
Obstetrics & Gynecology · 203d
Cleared Aug 08, 2025
Plain Water-based Lubricant
K243972 · NUC
Global Protection Corp.
Obstetrics & Gynecology · 228d
Cleared Aug 08, 2025
Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology
K243531 · JXG
Integra Lifesciences Production...
Neurology · 267d
Cleared Aug 08, 2025
MICOR 700 with Auto I/A
K243395 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 281d
Cleared Aug 08, 2025
Parkell Pit and Fissure Sealant
K243254 · EBC
Parkell, Inc.
Dental · 297d
Cleared Aug 07, 2025
LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)
K251667 · OHS
Shenzhen Liyoutong Technology Co., Ltd.
General & Plastic Surgery · 69d
Cleared Aug 07, 2025
UNiD™ Spine Analyzer
K251629 · QIH
Medicrea International S.A.S....
Radiology · 71d
Cleared Aug 07, 2025
GX1 Radiofrequency Generator Kit (RFG-X1-120V)
K251247 · GXD
Boston Scientific Neuromodulation...
Neurology · 106d
Cleared Aug 07, 2025
Navigo Workstation 2.3 (FPRMC00039)
K250664 · LLZ
UC-CARE , Ltd.
Radiology · 155d
Cleared Aug 07, 2025
Succession™ AFN System
K250622 · HSB
Ortho Solutions UK , Ltd.
Orthopedic · 160d
Cleared Aug 07, 2025
BTL-199
K250309 · QPL
BTL Industries, Inc.
Physical Medicine · 185d