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
5569–5592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 2024
AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask
K230915 · CCK
Vyaire Medical, Inc.
Anesthesiology · 592d
Cleared Nov 11, 2024
Straumann® Anatomic Healing Abutments XC (AHA)
K241575 · NHA
Straumann USA, LLC
Dental · 161d
Cleared Nov 09, 2024
esolution® Esophageal Retractor
K243233 · QXU
S4 Medical Corp.
Cardiovascular · 31d
Cleared Nov 08, 2024
Trigon PEEK HA Wedges
K243231 · PLF
Nvision Biomedical Technologies
Orthopedic · 30d
Cleared Nov 08, 2024
Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323,...
K243075 · ODC
STERIS Corporation
Gastroenterology & Urology · 42d
Cleared Nov 08, 2024
Xpine Spinal Fixation System
K243004 · NKB
Jeil Medical Corporation
Orthopedic · 43d
Cleared Nov 08, 2024
CLUNGENE Fentanyl Home Test Cassette
K242802 · NGL
Hangzhou Clongene Biotech Co., Ltd.
Toxicology · 52d
Cleared Nov 08, 2024
Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080,...
K242756 · DYB
Pulnovo Medical (Wuxi) Co., Ltd.
Cardiovascular · 57d
Cleared Nov 08, 2024
TopCEM Ceramic Primer Ceramic Coupling Agent
K242749 · KLE
Rizhao Huge Biomaterials Company, Ltd.
Dental · 57d
Cleared Nov 08, 2024
décoLITE LED Device
K242382 · OHS
iSMART Developments, Ltd.
General & Plastic Surgery · 88d
Cleared Nov 08, 2024
Superflow Prime Treatment System (ASP-1M)
K242286 · GEI
Guangzhou Aimira Innovation...
General & Plastic Surgery · 98d
Cleared Nov 08, 2024
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona...
K242231 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 101d
Cleared Nov 08, 2024
Device 300397 Putty
K241802 · MQV
Geistlich Pharma AG
Orthopedic · 140d
Cleared Nov 08, 2024
MobileLink Acetabular Cup System - Line Extension (Multiple)
K241636 · LPH
Waldemar Link GmbH & Co. KG
Orthopedic · 155d
Cleared Nov 08, 2024
Hybrid Viewer (00859873006189)
K241364 · KPS
Hermes Medical Solutions AB
Radiology · 178d
Cleared Nov 08, 2024
Hair Growth Comb (SZ-23,SZ-23A)
K241342 · OAP
Shenzhen Nuon Medical Equipment Co.,...
General & Plastic Surgery · 179d
Cleared Nov 08, 2024
Plasonic (Plasonic)
K241099 · GEI
Hironic Co., Ltd.
General & Plastic Surgery · 200d
Cleared Nov 08, 2024
Frontier X Plus
K240794 · MLO
Fourth Frontier Technologies Pvt, Ltd.
Cardiovascular · 231d
Cleared Nov 08, 2024
Microdacyn Hydrogel
K240510 · FRO
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 260d
Cleared Nov 08, 2024
ProFound Detection (V4.0)
K240417 · QDQ
Icad, Inc.
Radiology · 269d
Cleared Nov 07, 2024
ZSFab Cervical Interbody System
K242734 · ODP
Zsfab
Orthopedic · 58d
Cleared Nov 07, 2024
VioSeal
K242702 · KIF
Spident Co., Ltd.
Dental · 59d
Cleared Nov 07, 2024
Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
K242595 · OHT
Shenzhen Greatro Electronic...
General & Plastic Surgery · 69d
Cleared Nov 07, 2024
LL Implant System
K242379 · DZE
Ossvis Co., Ltd.
Dental · 87d