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
3241–3264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2025
Multi4 System
K250522 · FAS
Multi4 Medical AB
Gastroenterology & Urology · 126d
Cleared Jun 27, 2025
VIKING™ Fixed Curve Diagnostic Catheter
K250310 · DRF
Boston Scientific Corporation
Cardiovascular · 144d
Cleared Jun 27, 2025
eMotus Respiratory Motion Management System
K243900 · LHN
Empnia, Inc.
Radiology · 190d
Cleared Jun 27, 2025
Testa TP Pivoting Spacer System
K243816 · MAX
Spine Wave, Inc.
Orthopedic · 197d
Cleared Jun 27, 2025
SonoPlex STIM
K243682 · BSP
PAJUNK GmbH Medizintechnologie
Anesthesiology · 210d
Cleared Jun 27, 2025
Disposable Distal Cap
K243388 · FDS
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 239d
Cleared Jun 27, 2025
USTOMED Bone Fixation/Bone Augmentation Systems - PIN
K243190 · DZL
Ustomed Instrumente Ulrich Storz GmbH...
Dental · 270d
Cleared Jun 27, 2025
Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)
K243187 · OMP
Cork Medical
General & Plastic Surgery · 270d
Cleared Jun 27, 2025
RTMsense Respiratory Monitoring System
K243183 · BZQ
Rtm Vital Signs, LLC
Anesthesiology · 270d
Cleared Jun 27, 2025
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
K243144 · JOY
Scopio Labs , Ltd.
Hematology · 270d
Cleared Jun 27, 2025
Integral Dental Unit
K243130 · EIA
Guangdong Yadeng Medical Apparatus...
Dental · 270d
Cleared Jun 27, 2025
Affirm 800
K243077 · IZI
Digital Surgery Systems, Inc. (D.B.A...
Neurology · 270d
Cleared Jun 27, 2025
Genostis Osteosynthesis System
K242988 · HRS
Genostis AF
Orthopedic · 274d
Cleared Jun 26, 2025
Velacur One (LI-1100)
K251728 · IYO
Sonic Incytes Medical Corp
Radiology · 21d
Cleared Jun 26, 2025
Freedom® Total Knee System – Titanium Tibial Base Plate
K251717 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 22d
Cleared Jun 26, 2025
safety lancet
K251694 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 24d
Cleared Jun 26, 2025
Optimas MAX System
K251632 · GEX
Inmode , Ltd.
General & Plastic Surgery · 29d
Cleared Jun 26, 2025
SwissGraft X
K251613 · NPM
Geistlich Pharma AG
Dental · 30d
Cleared Jun 26, 2025
The Rialto™ SI Fusion System
K251395 · OUR
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 52d
Cleared Jun 26, 2025
Sherlock
K250967 · NHA
Open Implants, LLC
Dental · 87d
Cleared Jun 26, 2025
HardyDisk AST Gepotidacin 10µg (GEP10)
K250956 · JTN
Hardy Diagnostics
Microbiology · 87d
Cleared Jun 26, 2025
Atmo Gas Capsule System
K250940 · NYV
Atmo Biosciences, Ltd.
Gastroenterology & Urology · 90d
Cleared Jun 26, 2025
TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate)
K250929 · HRS
TriMed, Inc.
Orthopedic · 90d
Cleared Jun 26, 2025
Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
K250548 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 121d