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

Filters: 2026–2026 ×
2,517 results
73–96 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Sep 25, 2026
EPIQ Inspira Series Diagnostic Ultrasound System
K262548 · IYN
Philips Ultrasound, LLC
Radiology · 64d
Cleared Sep 25, 2026
Profoject™ Safety Sliding Blood Collection Set
K262215 · JKA
CMT Health PTE., Ltd.
General Hospital · 87d
Cleared Sep 25, 2026
Invisalign System
K262196 · PNN
Align Technology, Inc.
Dental · 88d
Cleared Sep 25, 2026
3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)
K261992 · JOJ
Solventum US, LLC
General Hospital · 102d
Cleared Sep 25, 2026
Braun Aura 9 (6042)
K261977 · OHT
Cyden Limited
General & Plastic Surgery · 105d
Cleared Sep 25, 2026
Profoject™ LOR Syringe
K261372 · CAZ
CMT Health PTE., Ltd.
Anesthesiology · 151d
Cleared Sep 25, 2026
Xpert Respiratory Panel
K261336 · QOF
Cepheid
Microbiology · 155d
Cleared Sep 25, 2026
Altis Full Face Mask
K261262 · BZD
Respironics, Inc.
Anesthesiology · 162d
Cleared Sep 25, 2026
Aevice Wheeze Detection Module
K260140 · PHZ
Aevice Health Pte. , Ltd.
Anesthesiology · 248d
Cleared Sep 25, 2026
syngo.CT Brain Quantification
K260055 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 260d
Cleared Sep 25, 2026
TumorSight Risk
K260023 · SHW
SimBioSys, Inc.
Pathology · 263d
Cleared Sep 25, 2026
Tempus ECG-MR
K254297 · SBQ
Tempus AI, Inc.
Cardiovascular · 268d
Cleared Sep 25, 2026
easyEndo™ E-Lite Single Use Powered Endoscopic Staplers
K254291 · GDW
Ezisurg Medical Co., Ltd.
General & Plastic Surgery · 268d
Cleared Sep 25, 2026
S-Patch CardioAI
K254255 · DPS
Wellysis Corp.
Cardiovascular · 270d
Cleared Sep 25, 2026
UNIDRIVE SIII System
K254252 · HIH
Karl Storz SE & CO. KG
Obstetrics & Gynecology · 270d
Cleared Sep 25, 2026
CapsoView (CVV)
K254230 · QZF
CapsoVision, Inc.
Gastroenterology & Urology · 270d
Cleared Sep 25, 2026
REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)
K254210 · NPM
Hyundai Bioland Co., Ltd.
Dental · 270d
Cleared Sep 25, 2026
DistaSense(TM) (v1)
K254058 · DRT
Life Detection Technologies
Cardiovascular · 282d
Cleared Sep 24, 2026
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
K263010 · GWF
Inomed Medizintechnik GmbH
Neurology · 27d
Cleared Sep 24, 2026
OsseoFit Stemless Shoulder System
K262955 · PKC
Zimmer, Inc.
Orthopedic · 31d
Cleared Sep 24, 2026
Arthrex Spine Compression FT Screw
K262618 · MRW
Arthrex, Inc.
Orthopedic · 58d
Cleared Sep 24, 2026
MPa Max adhesive
K262252 · KLE
Den-Mat Holdings, LLC
Dental · 84d
Cleared Sep 24, 2026
Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126,...
K262183 · OAP
Shenzhen Nuon Medical Equipment Co.,...
General & Plastic Surgery · 87d
Cleared Sep 24, 2026
QIAstat-Dx BCID GN Plus AMR Panel
K262168 · PEN
QIAGEN GmbH
Microbiology · 90d