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: 2026–2026 ×
1,642 results
841–864 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Apr 07, 2026
Warming System
K252861 · DWJ
Hangzhou Tappa Medical Technology...
Cardiovascular · 210d
Cleared Apr 07, 2026
Firefighter™ Pro PTCA Balloon Catheter
K252116 · LOX
Shanghai MicroPort Medical (Group)...
Cardiovascular · 274d
Cleared Apr 06, 2026
ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050,...
K260521 · FED
Zhuhai Pusen Medical Technology Co.,...
Gastroenterology & Urology · 48d
Cleared Apr 06, 2026
VANES Delivery System (VDS)
K260459 · DYB
Zoll Respicardia, Inc.
Cardiovascular · 54d
Cleared Apr 06, 2026
SYNERJET PRO (SP-1002)
K260397 · GEI
Hironic Co., Ltd.
General & Plastic Surgery · 59d
Cleared Apr 06, 2026
GLOSSY COAT (15ML)
K254091 · EBD
YAMAHACHI DENTAL MFG., Co.
Dental · 108d
Cleared Apr 06, 2026
AETOS Shoulder System - CONCELOC Glenoids
K254084 · KWS
Smith & Nephew, Inc.
Orthopedic · 109d
Cleared Apr 06, 2026
APERTO Lucent MRI System
K253862 · LNH
Fujifilm Corporation
Radiology · 124d
Cleared Apr 06, 2026
6450 Ultrasound System (MyLabE80)
K253288 · IYN
Esaote, S.P.A.
Radiology · 189d
Cleared Apr 06, 2026
Light-curing Coloring Materials (ALCM)
K253036 · EBF
Aidite (Qinhuangdao) Technology Co.,...
Dental · 196d
Cleared Apr 06, 2026
Ricoh 3D for Healthcare Bolus
K253025 · IXI
Ricoh 3D For Healthcare, LLC
Radiology · 199d
Cleared Apr 06, 2026
in2 Smart (in2S)
K252809 · QRC
Virility Medical , Ltd.
Gastroenterology & Urology · 215d
Cleared Apr 06, 2026
ProSomnus RPMO2 OSA Device (RPMO2 OSA)
K252765 · PLC
Prosomnus Sleep Technologies
Dental · 220d
Cleared Apr 06, 2026
SV70 Ventilator (SV70)
K252182 · MNT
Shenzhen Mindray Bio-Medical...
Anesthesiology · 269d
Cleared Apr 06, 2026
SPECTRA Wearable 2
K250208 · HGX
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology · 437d
Cleared Apr 03, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K260786 · NKB
S.M.A.I.O
Orthopedic · 24d
Cleared Apr 03, 2026
MAGENTIQ-COLO (ME-APDS)
K260724 · QNP
Magentiq Eye, Ltd.
Gastroenterology & Urology · 29d
Cleared Apr 03, 2026
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717)
K260720 · ETB
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 29d
Cleared Apr 03, 2026
mGRIP Total Prosthesis (3.00 mm) (58689)
K260719 · ETA
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 29d
Cleared Apr 03, 2026
mGRIP Partial Prosthesis (0.75 mm) (58669)
K260718 · ETB
Med-El Elektromedizinische Ger?te GmbH
Ear, Nose, Throat · 29d
Cleared Apr 03, 2026
uMI Panvivo (uMI Panvivo LS)
K260524 · KPS
Shanghai United Imaging Healthcare...
Radiology · 45d
Cleared Apr 03, 2026
Ceribell Brain Monitor Headband
K260363 · GXY
Ceribell, Inc.
Neurology · 58d
Cleared Apr 03, 2026
Single-use Video Scope
K254153 · FBN
Mirco-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 102d
Cleared Apr 03, 2026
Etiometry Platform
K254066 · PPW
Etiometry, Inc.
Cardiovascular · 106d