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
9337–9360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 2023
Reprocessed Agilis NxT Steerable Introducer
K230376 · PNE
Innovative Health, LLC
Cardiovascular · 175d
Cleared Aug 07, 2023
Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy...
K223713 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 238d
Cleared Aug 07, 2023
V-PRO maX 2 Low Temperature Sterilization System
K223476 · MLR
STERIS Corporation
General Hospital · 262d
Cleared Aug 07, 2023
SQA-iO Sperm Quality Analyzer
K220828 · POV
Medical Electronic Systems , Ltd.
Hematology · 503d
Cleared Aug 05, 2023
Stryker Resorbable Fixation System
K230733 · JEY
Stryker Leibinger GmbH & Co KG
Dental · 142d
Cleared Aug 04, 2023
iTEMPSHIELD
K232010 · FLL
Aion Biosystems, Inc.
General Hospital · 29d
Cleared Aug 04, 2023
LEGACY® IPC
K232006 · JOW
Ig Technology, Ltd.
Cardiovascular · 29d
Cleared Aug 04, 2023
HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue)
K232005 · MBI
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Aug 04, 2023
T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button,...
K231404 · MBI
Healthium Medtech Limited
Orthopedic · 81d
Cleared Aug 04, 2023
Bladeless Trocar – Artemis Lap Cannula
K231400 · GCJ
T.A.G. Medical Products Corporation,...
General & Plastic Surgery · 81d
Cleared Aug 04, 2023
Dewin Blastocyst Medium (with HSA and without HSA)
K231370 · MQL
Donnevie Medical Technology...
Obstetrics & Gynecology · 84d
Cleared Aug 04, 2023
STRETTO™ Cable System
K231333 · JDQ
Globus Medical, Inc.
Orthopedic · 88d
Cleared Aug 04, 2023
Annabella Breast Pump
K230672 · HGX
Annabella , Ltd.
Obstetrics & Gynecology · 147d
Cleared Aug 04, 2023
Dentis s-Clean Regular Abutment
K230126 · NHA
Dentis Co., Ltd.
Dental · 199d
Cleared Aug 04, 2023
ECGenius System
K223787 · DQK
Cath Vision Aps
Cardiovascular · 228d
Cleared Aug 04, 2023
Surgeon Controlled Arm
K223673 · PNL
Levita Magnetics International Corp
General & Plastic Surgery · 240d
Cleared Aug 04, 2023
CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)
K223507 · EBZ
Good Doctors Co., Ltd.
Dental · 255d
Cleared Aug 04, 2023
Citric Complete Liquid Citric Acid Concentrate
K223431 · KPO
Nipro Renal Solutions USA, Corp.
Gastroenterology & Urology · 263d
Cleared Aug 04, 2023
Premier Resolution System
K222635 · GKA
Trinity Biotech (Primus Corporation,...
Hematology · 338d
Cleared Aug 04, 2023
Titus Titanium Cervical by SAGICO
K221138 · OVE
Sagico VA USA, LLC
Orthopedic · 472d
Cleared Aug 04, 2023
Alinity h-series System
K220031 · GKZ
Abbott Laboratories
Hematology · 576d
Cleared Aug 03, 2023
LifeSPARC System
K232132 · KFM
Cardiacassist, Inc.
Cardiovascular · 16d
Cleared Aug 03, 2023
YosemiteView 4343W/YosemiteView 3643W
K232058 · MQB
Careray Digital Medical Technology...
Radiology · 23d
Cleared Aug 03, 2023
ATMOS Scope (507.7000.0)
K232015 · EOB
Atmos Medizintechnik GmbH & Co. KG
Ear, Nose, Throat · 28d