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
2833–2856 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2025
WinForth (LM-E470KA)
K250916 · PBX
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 140d
Cleared Aug 14, 2025
Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm...
K250898 · NLQ
Stryker Sustainability Solutions
General & Plastic Surgery · 142d
Cleared Aug 14, 2025
Cassette Autoclave (ACA5)
K250164 · FLE
Guangzhou Ajax Medical Equipment Co.,...
General Hospital · 205d
Cleared Aug 14, 2025
Stitch Cerclage – Suture Tapes
K243905 · JDQ
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 238d
Cleared Aug 14, 2025
3nethra neo HD FA
K243600 · HKI
Forus Health Pvt.Ltd
Ophthalmic · 266d
Cleared Aug 14, 2025
BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
K243544 · QOF
Biofire Diagnostics, LLC
Microbiology · 272d
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