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
2857–2880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 2025
14F Duo-Flow® Side X Side Double Lumen Catheter
K250836 · MPB
Medical Components, Inc.
Gastroenterology & Urology · 145d
Cleared Aug 12, 2025
DS Core Diagnosis
K250755 · QIH
Dentsply Sirona, Inc.
Radiology · 153d
Cleared Aug 12, 2025
Straumann® RidgeFit Implants
K250294 · DZE
Institut Straumann AG
Dental · 193d
Cleared Aug 12, 2025
CuffGuard
K243562 · BSK
Idmed
Anesthesiology · 267d
Cleared Aug 11, 2025
Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH)
K252211 · GEI
Cnc Technologies
General & Plastic Surgery · 27d
Cleared Aug 11, 2025
Saige-Dx
K251873 · QDQ
DeepHealth, Inc.
Radiology · 54d
Cleared Aug 11, 2025
External Fixation Bone Distractor
K251862 · KTT
Paragon 28, Inc.
Orthopedic · 55d
Cleared Aug 11, 2025
UE BRONCHO Single-Use Bronchoscopes (EBS-380C)
K251823 · EOQ
Zhejiang UE Medical Corp.
Ear, Nose, Throat · 59d
Cleared Aug 11, 2025
XERF
K251327 · GEI
Lutronic Corporation
General & Plastic Surgery · 103d
Cleared Aug 11, 2025
OxyMinder Pro (10310)
K251245 · CCL
Bio-Med Device, Inc.
Anesthesiology · 111d
Cleared Aug 11, 2025
MagVenture TMS Therapy System
K251125 · OBP
Tonica Elektronik A/S
Neurology · 122d
Cleared Aug 11, 2025
Identity Revision Humeral Stems
K251098 · MBF
Zimmer, Inc.
Orthopedic · 123d
Cleared Aug 11, 2025
UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
K250462 · FET
Univlabs Technologies Private Limited
General & Plastic Surgery · 174d
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