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
5785–5808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 2024
Eversense 365 Continuous Glucose Monitoring (CGM) System
K241335 · SBA
Senseonics, Incorporated
Chemistry · 126d
Cleared Sep 16, 2024
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10...
K241201 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 139d
Cleared Sep 16, 2024
Power Wheelchair (YH-E7007)
K240638 · ITI
Ningbo Youhuan Automation Technology...
Physical Medicine · 194d
Cleared Sep 16, 2024
DNA Appliance
K234089 · LRK
Vivos Therapeutics
Dental · 269d
Cleared Sep 16, 2024
HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization...
K234050 · FRG
O&M Halyard, Inc.
General Hospital · 270d
Cleared Sep 16, 2024
Traus SSG30 Surgical System
K232938 · HBC
Saeshin Precision Co., Ltd.
Neurology · 362d
Cleared Sep 14, 2024
Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology...
K241156 · NLH
Surgical Instrument Service and...
Cardiovascular · 141d
Cleared Sep 13, 2024
Revian Lyte (10011)
K242441 · OAP
Revian, Inc.
General & Plastic Surgery · 28d
Cleared Sep 13, 2024
TheRay Collared and Collarless Femoral Stem
K241875 · MEH
Nextstep Arthropedix
Orthopedic · 77d
Cleared Sep 13, 2024
Elos Accurate® Hybrid Base™
K241722 · NHA
Elos Medtech Pinol A/S
Dental · 91d
Cleared Sep 13, 2024
DenQ Sub SLA Implant System
K240977 · DZE
Denq
Dental · 156d
Cleared Sep 13, 2024
Sleep Apnea Notification Feature (SANF)
K240929 · QZW
Apple, Inc.
Anesthesiology · 162d
Cleared Sep 13, 2024
Epitomee
K240544 · QFQ
Epitomee Medical , Ltd.
Gastroenterology & Urology · 199d
Cleared Sep 13, 2024
EK D3.3 and Ultra Wide Implants
K240232 · DZE
Hiossen, Inc.
Dental · 228d
Cleared Sep 13, 2024
Vitruvian Liposaber
K240188 · QPB
Black & Black Surgical, Inc.
General & Plastic Surgery · 233d
Cleared Sep 13, 2024
V-VITFREEZE and V-VITWARM
K240176 · MQL
Vitromed GmbH
Obstetrics & Gynecology · 234d
Cleared Sep 13, 2024
RT Carbon ECG Leads
K240087 · DSA
Ivy Biomedical Systems, Inc.
Cardiovascular · 246d
Cleared Sep 13, 2024
T2Candida 1.1 Panel
K234063 · PII
T2biosystems, Inc.
Microbiology · 266d
Cleared Sep 13, 2024
Microdacyn Wound Care Solution
K233399 · FRO
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 345d
Cleared Sep 12, 2024
EXULT Knee Replacement System
K242401 · JWH
Corentec Co., Ltd.
Orthopedic · 30d
Cleared Sep 12, 2024
Electric wheelchair (C001)
K242136 · ITI
Zhejiang Hfizer Medical Equipment...
Physical Medicine · 52d
Cleared Sep 12, 2024
3M™ Attest™ Super Rapid Readout Biological Indicator 1492V
K241710 · FRC
3M Company
General Hospital · 90d
Cleared Sep 12, 2024
Extremity All Suture System
K241695 · MBI
Field Orthopaedics
Orthopedic · 92d
Cleared Sep 12, 2024
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900,...
K241582 · IYN
Canon Medical Systems Corporation
Radiology · 101d