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
10033–10056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 2023
Integrity™ Bone Staple Fixation System
K223860 · MBI
Anika Therapeutics, Inc.
Orthopedic · 150d
Cleared May 22, 2023
TrueBeam, TrueBeam STx, Edge, VitalBeam
K223839 · IYE
Varian Medical Systems, Inc.
Radiology · 151d
Cleared May 22, 2023
Introducer Needle
K222705 · LJE
Youcare Technology Co.,Ltd. (Wuhan)
General & Plastic Surgery · 257d
Cleared May 22, 2023
PVC Hydrophilic Urethral Catheter
K220722 · EZD
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 434d
Cleared May 19, 2023
GI Genius System 100 and GI Genius System 200
K231143 · QNP
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology · 28d
Cleared May 19, 2023
aprevo® transforaminal lumbar interbody fusion device
K231140 · MAX
Carlsmed, Inc.
Orthopedic · 28d
Cleared May 19, 2023
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
K231137 · DKZ
Xenta Biomedical Science Co., Ltd.
Toxicology · 28d
Cleared May 19, 2023
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c...
K230790 · DHA
Abbott Laboratories
Chemistry · 58d
Cleared May 19, 2023
PrevisEA Device
K230769 · DQD
Entac Medical, Inc.
Gastroenterology & Urology · 60d
Cleared May 19, 2023
Klassic Knee Revision System
K230537 · JWH
Total Joint Othopedics, Inc.
Orthopedic · 81d
Cleared May 19, 2023
Triathlon® Hinge Knee System
K230416 · KRO
Stryker
Orthopedic · 92d
Cleared May 19, 2023
BIOMONITOR IV
K230375 · MXD
Biotronik, Inc.
Cardiovascular · 95d
Cleared May 19, 2023
iLet® ACE Pump
K223846 · QFG
Beta Bionics, Inc.
Chemistry · 150d
Cleared May 19, 2023
SafeBreak® Vascular
K223486 · QOI
Lineus Medical
General Hospital · 179d
Cleared May 19, 2023
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W
K222979 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 233d
Cleared May 19, 2023
Ventana™ C Spinal System
K222833 · ODP
Spinal Elements, Inc.
Orthopedic · 241d
Cleared May 19, 2023
ATTO Mobility Scooter (ATTO)
K222703 · INI
Moving Life, Ltd.
Physical Medicine · 254d
Cleared May 19, 2023
Disposable Medical Mask
K222545 · FXX
Guangzhou Fuzelong Hygiene Material...
General Hospital · 270d
Cleared May 19, 2023
Exactech® Alteon® Short Tapered Wedge
K221323 · LZO
Exactech, Inc.
Orthopedic · 378d
Cleared May 19, 2023
iLet® Dosing Decision Software
K220916 · QJI
Beta Bionics, Inc.
Chemistry · 415d
Cleared May 19, 2023
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors,...
K220842 · KFM
Qura S.R.L
Cardiovascular · 422d
Cleared May 19, 2023
VirtuOst
K220402 · KGI
O.N. Diagnostics
Radiology · 462d
Cleared May 19, 2023
Autoplaque
K212758 · LLZ
Cedars-Sinai Medical Center: Aim
Radiology · 626d
Cleared May 18, 2023
Arthrex FiberTak Suture Anchor
K231113 · MBI
Arthrex, Inc.
Orthopedic · 29d