FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
4825–4848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 2025
GraftGun Universal Graft Delivery System (GDS)
K243580 · FMF
SurGenTec, LLC
Orthopedic · 78d
Cleared Feb 05, 2025
LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B,...
K243555 · OLP
Shenzhen Eyco Technology Co., Ltd.
General & Plastic Surgery · 79d
Cleared Feb 05, 2025
CROMA Electrosurgical Generator (PRD-EMR-050)
K242983 · GEI
Creo Medical, Ltd.
General & Plastic Surgery · 132d
Cleared Feb 05, 2025
Caliber Intramedullary Fixation System
K242896 · HWC
Nvision Biomedical Technologies
Orthopedic · 135d
Cleared Feb 05, 2025
Accurate Mini Non-invasive blood pressure monitor (AMB-001)
K242352 · DXN
Accurate Meditech, Inc.
Cardiovascular · 181d
Cleared Feb 05, 2025
BoneMetrics (US)
K241593 · QIH
Gleamer Sas
Radiology · 247d
Cleared Feb 05, 2025
TrainFES Advance
K241488 · IPF
Trainfes
Physical Medicine · 257d
Cleared Feb 05, 2025
Navient Image Guide Navigation System (955-NC-NC), Cranial
K241327 · HAW
Claronav
Neurology · 271d
Cleared Feb 04, 2025
Venclose digiRF Generator (VCRFG1)
K250068 · GEI
Venclose, Inc.
General & Plastic Surgery · 25d
Cleared Feb 04, 2025
rTOP
K243333 · LLZ
Roclub GmbH
Radiology · 103d
Cleared Feb 04, 2025
Geon (S2) Nasal Aspirator
K243138 · BTA
Geon Corporation
Ear, Nose, Throat · 127d
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