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
3121–3144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 2025
S.I.N. Dental Implant System
K251046 · DZE
S.I.N. Implant System Ltda
Dental · 132d
Cleared Aug 13, 2025
Unscented menstrual long applicator tampon
K251033 · HEB
Unibeauty (Hubei) Technology Co., Ltd.
Obstetrics & Gynecology · 132d
Cleared Aug 13, 2025
Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117)
K250931 · DQA
Unimed Medical Supplies, Inc.
Anesthesiology · 138d
Cleared Aug 13, 2025
Electrotherapy Electrodes
K250841 · GXY
Baisheng Medical Co., Ltd.
Neurology · 146d
Cleared Aug 13, 2025
T2 Alpha Femur Retrograde Nailing System
K250163 · HSB
Stryker GmbH
Orthopedic · 204d
Cleared Aug 13, 2025
KARL STORZ HOPKINS Telescopes for Urology
K243653 · FAJ
Karl Storz SE & CO. KG
Gastroenterology & Urology · 260d
Cleared Aug 13, 2025
AeroJet Ventilation Catheter
K243579 · BTR
Pipeline Medical Products, LLC
Anesthesiology · 267d
Cleared Aug 13, 2025
DOLORCLAST Focused Shock Waves
K243279 · PZL
E.M.S Electro Medical Systems S.A
General & Plastic Surgery · 301d
Cleared Aug 12, 2025
HOTWIRE™ System RF Generator and Footswitch (optional accessory)
K252083 · GEI
Atraverse Medical, Inc.
General & Plastic Surgery · 41d
Cleared Aug 12, 2025
Sulopenem SPM 2 µg
K251879 · JTN
Liofilchem
Microbiology · 55d
Cleared Aug 12, 2025
Eko Foundation Analysis Software with Transformers (EFAST)
K251494 · DQD
Eko Health, Inc.
Cardiovascular · 89d
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