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
1417–1440 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jan 29, 2026
Y-Knotless™ Flex Anchors
K253763 · MBI
Conmed Corporation
Orthopedic · 65d
Cleared Jan 29, 2026
Manual Wheelchair (W50)
K253632 · IOR
Jiangsu Jumao X-Care Medical...
Physical Medicine · 71d
Cleared Jan 29, 2026
Falco Fusion System
K253611 · OUR
Mcnicoll Surgical, Inc.
Orthopedic · 72d
Cleared Jan 29, 2026
NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
K253462 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 114d
Cleared Jan 29, 2026
Labcorp Fentanyl Urine Visual Test
K252684 · DJG
Medtox Diagnostics, Inc.
Toxicology · 157d
Cleared Jan 29, 2026
Neurophet AQUA AD Plus
K252496 · QIH
Neurophet., Inc.
Radiology · 174d
Cleared Jan 29, 2026
Electric Scooter (Mojo-T330)
K252349 · INI
Dongguan Smarfody Mobility Technology...
Physical Medicine · 184d
Cleared Jan 29, 2026
Electric Scooter (Mojo-T580)
K252347 · INI
Dongguan Smarfody Mobility Technology...
Physical Medicine · 184d
Cleared Jan 29, 2026
Electric Scooter (DDF100)
K252275 · INI
Zhejiang Nysin Medical Co., Ltd.
Physical Medicine · 191d
Cleared Jan 29, 2026
Surgical Reality Viewer
K252091 · QIH
Medicalvr B.V.
Radiology · 210d
Cleared Jan 29, 2026
Medical Shaver System (Morcellator) (YSB-IIIA)
K251923 · GCJ
Hangzhou Hawk Optical Electronic...
Gastroenterology & Urology · 220d
Cleared Jan 29, 2026
EK MULTI ANGLED 30 ABUTMENT
K251427 · NHA
Hiossen, Inc.
Dental · 266d
Cleared Jan 29, 2026
UV Smart D60
K251354 · SCS
UV Smart Technologies B.V.
General Hospital · 274d
Cleared Jan 29, 2026
EZ-Protect Hydrophilic Closed System Intermittent Catheter
K251274 · EZD
HR Healthcare
Gastroenterology & Urology · 280d
Cleared Jan 29, 2026
Multi-Unit DAS System
K243732 · NHA
Talladium Espa?a, SL
Dental · 421d
Cleared Jan 28, 2026
Aevumed PROTEKT Suture Anchor
K260004 · MBI
Aevumed, Inc.
Orthopedic · 26d
Cleared Jan 28, 2026
Vena MicroAngioscope™ System
K253842 · LYK
Vena Medical Holdings Corp
Cardiovascular · 57d
Cleared Jan 28, 2026
Sleepiz One+ (Model 2.5)
K253388 · DRT
Sleepiz AG
Cardiovascular · 120d
Cleared Jan 28, 2026
GBT Machine Airflow Prophylaxis Master
K253254 · ELC
E.M.S Electro Medical Systems S.A
Dental · 121d
Cleared Jan 28, 2026
MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
K253224 · OBH
ImpediMed Limited
Gastroenterology & Urology · 121d
Cleared Jan 28, 2026
Sacroiliac Joint Truss System (SJTS)
K252834 · OUR
4Web Medical
Orthopedic · 145d
Cleared Jan 28, 2026
HIGHERDOSE Body Sculptor (Model: GS-03)
K252603 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 163d
Cleared Jan 28, 2026
NorthStar™ Mapping System
K252164 · DQK
Imricor Medical Systems
Cardiovascular · 202d
Cleared Jan 28, 2026
FreedomEdge Infusion System
K252015 · FRN
Koru Medical Systems, Inc.
General Hospital · 215d