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
4561–4584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 2025
Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens
K242916 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 133d
Cleared Feb 03, 2025
Contour ProtégéAI+
K250035 · QKB
Mim Software, Inc.
Radiology · 27d
Cleared Feb 03, 2025
Tiger 2 System
K243908 · NKB
Zavation Medical Products, LLC
Orthopedic · 46d
Cleared Feb 03, 2025
JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK,...
K243393 · NFO
Shenzhen Ulike Smart Electronics Co.,...
Neurology · 95d
Cleared Feb 03, 2025
TipTraQ (TTQ001)
K243268 · MNR
Pranaq Pte. , Ltd.
Anesthesiology · 111d
Cleared Feb 03, 2025
Anovo Instrument ARM Curved Scissors
K243182 · QNM
Momentis Surgical , Ltd.
General & Plastic Surgery · 126d
Cleared Feb 03, 2025
iCare APP
K243146 · MWI
Ihealth Labs, Inc.
Cardiovascular · 126d
Cleared Feb 03, 2025
Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08,...
K241590 · DXN
Guangdong Xinyu Electronic and...
Cardiovascular · 245d
Cleared Feb 03, 2025
Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY,...
K241454 · MQK
Guangzhou Hehong Biotech Co., Ltd.
Obstetrics & Gynecology · 257d
Cleared Feb 03, 2025
IdentiTi Porous Ti Interbody System
K241375 · MAX
Alphatec Spine
Orthopedic · 264d
Cleared Feb 03, 2025
Sonicaid Team3
K241368 · HGM
Huntleigh Healthcare , Ltd.
Obstetrics & Gynecology · 265d
Cleared Feb 03, 2025
Cito CBC System
K240402 · GKZ
Cytochip, Inc.
Hematology · 360d
Cleared Jan 31, 2025
Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s...
K243820 · FED
Dornier Medtech America
Gastroenterology & Urology · 50d
Cleared Jan 31, 2025
Arthrex DynaNite Nitinol Staples
K243742 · JDR
Arthrex, Inc.
Orthopedic · 58d
Cleared Jan 31, 2025
Crius PEEK Suture Anchor System (Thread-Fix Anchor)
K243665 · MBI
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 65d
Cleared Jan 31, 2025
Game Ready system (550500-04)
K243572 · IRP
Avanos Medical, Inc.
Physical Medicine · 74d
Cleared Jan 31, 2025
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs,...
K243441 · LZA
Basic Medical Technology, Inc.
General Hospital · 86d
Cleared Jan 31, 2025
Nuance Audio Hearing Aid Software
K243150 · SCR
Luxottica Group S.P.A.
Ear, Nose, Throat · 123d
Cleared Jan 31, 2025
Mobility Scooter (MS160A)
K242982 · INI
Suzhou Master Machinery Manufacturing...
Physical Medicine · 127d
Cleared Jan 31, 2025
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
K242966 · DQO
Gentuity, LLC
Cardiovascular · 127d
Cleared Jan 31, 2025
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
K242442 · HWC
Innovate Orthopaedics, Ltd.
Orthopedic · 168d
Cleared Jan 31, 2025
Synthgene Home Test HCG Test Strip
K242135 · LCX
Nanjing Synthgene Medical Technology...
Chemistry · 193d
Cleared Jan 31, 2025
ZeTTA PACS
K241694 · LLZ
Tae Young Soft Co., Ltd.
Radiology · 233d
Cleared Jan 31, 2025
SwimCount® Harvester (1 mL)
K241348 · MQK
Motilitycount Aps
Obstetrics & Gynecology · 263d