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
8329–8352 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 2023
EKGenius Smart System
K232974 · DPS
Ekgenius, LLC
Cardiovascular · 57d
Cleared Nov 17, 2023
Gastric Alimetry System
K232925 · MYE
Alimetry , Ltd.
Gastroenterology & Urology · 59d
Cleared Nov 17, 2023
DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR...
K232538 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 87d
Cleared Nov 17, 2023
Masimo W1
K232512 · DPS
Masimo Corporation
Cardiovascular · 91d
Cleared Nov 17, 2023
AI Platform (AIP001)
K232501 · QIH
Exo, Inc.
Radiology · 92d
Cleared Nov 17, 2023
Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100)
K232028 · FDS
Iq Endoscopes Limited
Gastroenterology & Urology · 133d
Cleared Nov 17, 2023
SENDERO Microcatheter
K231600 · DQY
Okami Medical, Inc.
Cardiovascular · 169d
Cleared Nov 17, 2023
Multi-Unit DAS System
K231559 · NHA
Talladium Espa?a, SL
Dental · 171d
Cleared Nov 17, 2023
Alinity c Tricyclic Antidepressants Reagent Kit
K231020 · LFH
Microgenics Corporation
Toxicology · 221d
Cleared Nov 17, 2023
Samfilcon B Custom Contact Lens
K230954 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 227d
Cleared Nov 17, 2023
Edwards Algorithm for Measurement of Blood Hemoglobin
K230612 · MUD
Edwards Lifesciences, LLC
Cardiovascular · 256d
Cleared Nov 17, 2023
Celox Rapid X-Ray Gauze
K230589 · QSY
Medtrade Products , Ltd.
General & Plastic Surgery · 260d
Cleared Nov 17, 2023
Polyver Silver Alginate Dressing (Prescription and OTC)
K230190 · FRO
Roosin Medical Co., Ltd.
General & Plastic Surgery · 297d
Cleared Nov 16, 2023
Vital™ Navigation System
K233443 · OLO
Zimvie Spine (Zimmer Biomet Spine, Inc.)
Orthopedic · 28d
Cleared Nov 16, 2023
OSSIOfiber® Compression Staple
K233302 · MNU
OSSIO , Ltd.
Orthopedic · 48d
Cleared Nov 16, 2023
XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
K233200 · OWB
GEMSS HEALTHCARE CO., LTD.
Radiology · 49d
Cleared Nov 16, 2023
Trio-CT­® Triple Lumen Catheter w/ Curved Extensions
K232945 · NIE
Medical Components, Inc. (dba MedComp)
Gastroenterology & Urology · 57d
Cleared Nov 16, 2023
DAILIES TOTAL1®
K232921 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 58d
Cleared Nov 16, 2023
EXPD 4343D
K232753 · MQB
DRTECH Corporation
Radiology · 69d
Cleared Nov 16, 2023
ROSA Partial Knee System
K232533 · OLO
Orthosoft D/B/A Zimmer Cas
Orthopedic · 87d
Cleared Nov 16, 2023
ExactechGPS® Total Ankle Application
K232521 · OLO
Blue Ortho
Orthopedic · 90d
Cleared Nov 16, 2023
CT Lung Ventilation Analysis Software (CT:V)
K232392 · JAK
4Dmedical Limited
Radiology · 99d
Cleared Nov 16, 2023
Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
K232139 · LPL
Innova Vision, Inc.
Ophthalmic · 121d
Cleared Nov 16, 2023
NEUWAVE™ Microwave Ablation System and Accessories
K231738 · NEY
Neuwave Medical, Inc.
General & Plastic Surgery · 155d