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
7393–7416 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 2024
Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix
K240424 · MQV
Collagen Matrix, Inc.
Orthopedic · 28d
Cleared Mar 12, 2024
Tranquil-C Interbody System
K240416 · ODP
Nexus Spine, LLC
Orthopedic · 29d
Cleared Mar 12, 2024
EmoLED (v. 2-USA)
K240132 · GEX
Emoled, Srl
General & Plastic Surgery · 55d
Cleared Mar 12, 2024
DRX-Evolution Plus System
K233381 · KPR
Carestream Health, Inc.
Radiology · 162d
Cleared Mar 12, 2024
Align Studio
K232564 · PNN
Laon Medi, Inc.
Dental · 201d
Cleared Mar 12, 2024
MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A
K231849 · KDJ
Baxter Healthcare
Gastroenterology & Urology · 263d
Cleared Mar 11, 2024
Caphosol® Artifical Saliva (32 doses sachet box)
K234015 · LFD
Eusa Pharma (Uk) Limited
Dental · 83d
Cleared Mar 11, 2024
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
K234000 · LON
bioMerieux, Inc.
Microbiology · 84d
Cleared Mar 11, 2024
SP NEWTRON CAN-A
K233922 · ELC
Satelec - Acteon Group
Dental · 89d
Cleared Mar 11, 2024
ARIX Cannulated Screw System
K233912 · HWC
Jeil Medical Corporation
Orthopedic · 90d
Cleared Mar 11, 2024
28mm/38D MDM X3 Insert for MDM Liner
K233724 · LZO
Howmedica Osteonics Corp., Dba...
Orthopedic · 111d
Cleared Mar 11, 2024
OTS Hip
K232140 · OLO
Ortoma AB
Orthopedic · 237d
Cleared Mar 11, 2024
Fiber Optic Brushless Electronic Micromotor, model: iM100
K231864 · EBW
Codent Technical Industry Co., Ltd.
Dental · 259d
Cleared Mar 11, 2024
Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)
K231789 · NGX
Guangzhou Xinbo Electronic Co., Ltd.
Physical Medicine · 265d
Cleared Mar 11, 2024
NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
K231758 · QOF
Luminex Molecular Diagnostics, Inc.
Microbiology · 269d
Cleared Mar 09, 2024
Osteon Precision Milled Suprastructure
K233083 · NHA
Implant Solutions Pty Ltd (Aka Osteon...
Dental · 165d
Cleared Mar 08, 2024
Elite iQ PRO (M122K1)
K240396 · GEX
Cynosure, LLC
General & Plastic Surgery · 29d
Cleared Mar 08, 2024
SENDERO Microcatheter
K240384 · DQY
Okami Medical, Inc.
Cardiovascular · 29d
Cleared Mar 08, 2024
Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A,...
K240264 · OHT
Shenzhen Mlay Intelligent Technology...
General & Plastic Surgery · 37d
Cleared Mar 08, 2024
WallFlex Colonic Stent System with Anchor Lock Delivery System
K234046 · MQR
Boston Scientific Corporation
Gastroenterology & Urology · 78d
Cleared Mar 08, 2024
Affera Mapping System (AFR-00003)
K233943 · DQK
Medtronic, Inc.
Cardiovascular · 85d
Cleared Mar 08, 2024
Knee+
K233899 · SBF
Pixee Medical
Orthopedic · 88d
Cleared Mar 08, 2024
Trivicta™ Hip Stem
K233758 · MEH
Ortho Development Corp.
Orthopedic · 105d
Cleared Mar 08, 2024
CellFX Percutaneous Electrode System (SYS3000)
K233705 · GEI
Pulse Biosciences, Inc.
General & Plastic Surgery · 109d