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
4825–4848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 02, 2025
Rist 079 Radial Access Guide Catheter
K241388 · QJP
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 232d
Cleared Jan 02, 2025
Haemostasis Clips
K241005 · PKL
Jiangxi Zhuoruihua Medical Instrument...
Gastroenterology & Urology · 265d
Cleared Dec 31, 2024
Idys® LIF
K243670 · MAX
Clariance
Orthopedic · 34d
Cleared Dec 31, 2024
Nasal Pillow Mask - Small (NNPM-01/ Nefes S)
K243225 · BZD
Genadyne Biotechnologies, Inc.
Anesthesiology · 84d
Cleared Dec 31, 2024
MitraClip™ G5 Steerable Guide Catheter (SGC0801)
K243224 · DQY
Abbott Medical
Cardiovascular · 85d
Cleared Dec 31, 2024
Electric Wheelchair (MODEL H)
K242989 · ITI
Nanjing E-Take Medical Apparatus Co.,...
Physical Medicine · 96d
Cleared Dec 31, 2024
Power Wheelchair (D10, D12, D15, D17, D20, D37)
K242468 · ITI
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 133d
Cleared Dec 31, 2024
Nasal Aspirator (NS 13)
K241852 · BTA
Avita Corporation
Ear, Nose, Throat · 187d
Cleared Dec 31, 2024
Peak Flow Meter
K241338 · BZH
Chongqing Moffy Innovation Technology...
Anesthesiology · 232d
Cleared Dec 30, 2024
Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
K243445 · GEX
Bios S.R.L.
General & Plastic Surgery · 54d
Cleared Dec 30, 2024
AF531 Oro-Nasal SE Face Mask
K243394 · CBK
Respironics, Inc.
Anesthesiology · 60d
Cleared Dec 30, 2024
PAL Aspiration System
K242804 · QPB
Microaire Surgical Instruments, LLC
General & Plastic Surgery · 104d
Cleared Dec 30, 2024
Next Generation Access Platform
K242376 · QJP
Balt USA, LLC
Neurology · 143d
Cleared Dec 28, 2024
8MP Color LCD Displays C811W, C811WT, PA27 and PA27T
K233119 · PZZ
Shenzhen Beacon Display Technology...
Pathology · 458d
Cleared Dec 27, 2024
TiLink-P SI Joint Fusion System
K243835 · OUR
SurGenTec, LLC
Orthopedic · 14d
Cleared Dec 27, 2024
BioTraceIO Precision (2.0)
K243084 · QZL
Techsomed Medical Technologies , Ltd.
Radiology · 88d
Cleared Dec 27, 2024
FLASH EVD System (10-0002)
K242480 · HAW
7D Surgical ULC
Neurology · 128d
Cleared Dec 27, 2024
Power Wheelchair
K242252 · ITI
Anhui Jbh Medical Apparatus Co., Ltd.
Physical Medicine · 149d
Cleared Dec 27, 2024
BLUEDIAMOND IMPLANT
K241972 · DZE
Megagen Implant Co., Ltd.
Dental · 175d
Cleared Dec 27, 2024
Elastic Impression Material
K241924 · ELW
Beijing Okvd Biological Technology ,...
Dental · 179d
Cleared Dec 27, 2024
INNO SLA Mini Plus® Implant System
K241127 · DZE
Cowellmedi Co., Ltd.
Dental · 248d
Cleared Dec 27, 2024
OEC One ASD
K240828 · OXO
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 276d
Cleared Dec 26, 2024
iovera° System
K243677 · GXH
Pacira Biosciences, Inc.
Neurology · 29d
Cleared Dec 26, 2024
TMC Compression Implant System
K243658 · JDR
Treace Medical Concepts
Orthopedic · 29d