FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
11641–11664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 2023
Saneso Lens Wash Bottle Assembly (SAN-LWB-A)
K222173 · OCX
Saneso, Inc.
Gastroenterology & Urology · 221d
Cleared Feb 27, 2023
Milli Vaginal Dilator
K220035 · HDX
Materna Medical
Obstetrics & Gynecology · 418d
Cleared Feb 27, 2023
Idylla MSI Test
K211181 · PZJ
Biocartis NV
Pathology · 678d
Cleared Feb 26, 2023
Handheld Pulse Oximeter
K213431 · DQA
Shenzhen Witleaf Medical Electronics...
Anesthesiology · 493d
Cleared Feb 25, 2023
CompuFlo Epidural Computer Controlled Anesthesia System
K221702 · FMF
Milestone Scientific, Inc.
Anesthesiology · 257d
Cleared Feb 24, 2023
EsoCheck Cell Collection Device
K230339 · EOX
Lucid Diagnostics, Inc.
Gastroenterology & Urology · 17d
Cleared Feb 24, 2023
Veloxion System
K230205 · FJL
Corinth Medtech, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 24, 2023
babyLance Safety Heelstick (BLM, BLN, BLP)
K223900 · FMK
Clinical Innovations, LLC
General & Plastic Surgery · 58d
Cleared Feb 24, 2023
ELITONE Urge Urinary Incontinence Device
K223884 · QAJ
Elidah, Inc.
Gastroenterology & Urology · 59d
Cleared Feb 24, 2023
VySpan™ PCT System
K223852 · NKG
Vy Spine, LLC
Orthopedic · 64d
Cleared Feb 24, 2023
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
K223810 · JKA
Sb-Kawasumi Laboratories, Inc.
General Hospital · 66d
Cleared Feb 24, 2023
Arthrex SynergyID Endoscopic Imaging System
K223759 · GCJ
Arthex, Inc.
General & Plastic Surgery · 71d
Cleared Feb 24, 2023
MectaLock TI Triple Loaded Suture Anchor
K223582 · MBI
Medacta International S.A.
Orthopedic · 85d
Cleared Feb 24, 2023
Ti-Largo Cervical Interbody System
K223231 · ODP
Flospine
Orthopedic · 129d
Cleared Feb 24, 2023
Clarus Viewer
K222757 · LLZ
Clarus Viewer Corporation
Radiology · 165d
Cleared Feb 24, 2023
Visionbody
K222386 · NGX
Vb Technologies AG
Physical Medicine · 200d
Cleared Feb 24, 2023
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
K221845 · NXC
Blue Sky Bio, LLC
Dental · 245d
Cleared Feb 24, 2023
TytoCare Lung Sounds Analyzer
K221614 · PHZ
Tyto Care , Ltd.
Anesthesiology · 266d
Cleared Feb 24, 2023
AVIEW Lung Nodule CAD
K221592 · OEB
Coreline Soft Co., Ltd.
Radiology · 267d
Cleared Feb 24, 2023
RealNow
K213891 · LLZ
Yiwei Medical Technology Co., Ltd.
Radiology · 437d
Cleared Feb 24, 2023
MAGNETOM Vida
K213805 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 445d
Cleared Feb 24, 2023
InnoGenic Non-resorbable Membrane
K211554 · NPK
Cowellmedi Co., Ltd.
Dental · 646d
Cleared Feb 23, 2023
Jumong General
K230241 · KPR
Sg Healthcare Co, Ltd.
Radiology · 24d
Cleared Feb 23, 2023
Iridex 532 Laser
K230228 · HQF
Iridex Corporation
Ophthalmic · 27d