Search FDA 510(k) Devices

5,468 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
1945–1968 of 174,061
Cleared Aug 14, 2025
mOm Essential Incubator (ME1)
K243437 · FMZ
Mom Incubators Limited
General Hospital · 282d
Cleared Aug 13, 2025
Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101)
K252226 · NQJ
Nuwellis, Inc.
Gastroenterology & Urology · 28d
Cleared Aug 13, 2025
HS Fiber
K252201 · GAT
Riverpoint Medical
General & Plastic Surgery · 30d
Cleared Aug 13, 2025
Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)
K252192 · HGX
Huizhou Lvb Maternal and Infant...
Obstetrics & Gynecology · 30d
Cleared Aug 13, 2025
Bone Screw
K251569 · DZL
Osstem Implant Co., Ltd.
Dental · 83d
Cleared Aug 13, 2025
RelieVRx (Pico G3)
K251519 · QRA
Appliedvr
Physical Medicine · 89d
Cleared Aug 13, 2025
MBT Compass HT CA Software
K251495 · QBN
Bruker Daltonics GmbH & Co. KG
Microbiology · 90d
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