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
5785–5808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2024
NOVA Minimally Invasive System
K242899 · NKB
Baui Biotech Co., Ltd.
Orthopedic · 24d
Cleared Oct 17, 2024
Ascent Cardiorespiratory Diagnostic Software
K242809 · BTY
Medical Graphics Corporation
Anesthesiology · 30d
Cleared Oct 17, 2024
IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)
K242197 · OHT
Shenzhen Huaruibo Electric Appliances...
General & Plastic Surgery · 83d
Cleared Oct 17, 2024
Electrically powered wheelchair (HP202)
K241337 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 157d
Cleared Oct 17, 2024
Hidroxa SE30
K241267 · EGJ
Hidroxa Medical AB
Physical Medicine · 164d
Cleared Oct 17, 2024
SIGNA MAGNUS
K241242 · LNH
Ge Medical Systems, LLC
Radiology · 167d
Cleared Oct 17, 2024
Zipline Access Catheter
K240711 · QJP
Perfuze, Ltd.
Neurology · 216d
Cleared Oct 17, 2024
REMI-AI Rapid Detection Module (REMI-AI RDM)
K240408 · OMB
Epitel, Inc.
Neurology · 251d
Cleared Oct 17, 2024
MP Pin flat without thread (36BMP000020/MP20)
K240321 · DZL
Hager& Meisinger GmbH
Dental · 258d
Cleared Oct 17, 2024
Electric Breast Pump (F5055)
K240218 · HGX
Fimilla (Shanghai) Maternity & Baby...
Obstetrics & Gynecology · 265d
Cleared Oct 17, 2024
EGPS Navigated Instruments
K240160 · OLO
Astura Medical
Orthopedic · 272d
Cleared Oct 17, 2024
Microlyte Ag/Lidocaine
K211943 · FRO
Imbed Biosciences
General & Plastic Surgery · 1212d
Cleared Oct 16, 2024
Safe Secure Sterilization Pouches and Rolls
K242839 · FRG
Shenzhen Safesecure Medical Infection...
General Hospital · 27d
Cleared Oct 16, 2024
ONCOZENE Microspheres
K242794 · KRD
Varian Medical Systems, Inc.
Cardiovascular · 30d
Cleared Oct 16, 2024
Vy Spine™ VyLam™ Laminoplasty System
K242784 · NQW
Vy Spine, LLC
Orthopedic · 30d
Cleared Oct 16, 2024
JLK-CTP
K242556 · LLZ
JLK, Inc.
Radiology · 49d
Cleared Oct 16, 2024
Electrically powered wheelchair
K241632 · ITI
Kunshan Hi-Fortune Health Products...
Physical Medicine · 132d
Cleared Oct 16, 2024
Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205,...
K241613 · DXN
Shenzhen Hbcare Technology Co.,Ltd
Cardiovascular · 133d
Cleared Oct 16, 2024
xvision Spine System
K241481 · SBF
Augmedics, Ltd.
Orthopedic · 145d
Cleared Oct 16, 2024
Stryker Steri-Shield 8 Surgical Hoods and Togas
K241272 · FYA
Stryker Instruments
General Hospital · 163d
Cleared Oct 16, 2024
CEREGLIDE 42 Intermediate Catheter
K241244 · QJP
Cerenovus, Inc.
Neurology · 167d
Cleared Oct 16, 2024
CEREGLIDE 42 Intermediate Catheter
K241221 · NRY
Cerenovus, Inc.
Neurology · 168d
Cleared Oct 16, 2024
Ambu® aScope™ 5 Cysto HD (Standard Deflection)
K240849 · FAJ
Ambu A/S
Gastroenterology & Urology · 203d
Cleared Oct 16, 2024
Cerebral Autoregulation Index (CAI) Algorithm
K240596 · MUD
Edwards Lifesciences
Neurology · 226d