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
8617–8640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 16, 2023
MASADA Modular Spinal Fixation System
K231694 · NKB
Astura Medical
Orthopedic · 160d
Cleared Nov 16, 2023
D100 KIDS
K231652 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 163d
Cleared Nov 16, 2023
LINK Embrace Shoulder System - Reverse Configuration
K231445 · PHX
Waldemar Link GmbH & Co. KG
Orthopedic · 182d
Cleared Nov 16, 2023
Aptima® Chlamydia trachomatis Assay
K230451 · MKZ
Hologic, Inc.
Microbiology · 268d
Cleared Nov 15, 2023
Arthrex Knee FiberTak® Button Suture Anchor
K232973 · MBI
Arthrex, Inc.
Orthopedic · 55d
Cleared Nov 15, 2023
Axial3D Insight
K232841 · QIH
Axial Medical Printing Limited
Radiology · 62d
Cleared Nov 15, 2023
BinkieRT
K231852 · IYE
Papricalab
Radiology · 145d
Cleared Nov 15, 2023
METIC™- Airway Balloon Catheter
K231818 · KTI
M/S Meril Life Sciences Pvt. , Ltd.
Ear, Nose, Throat · 147d
Cleared Nov 15, 2023
CoolSeal Trinity
K231012 · GEI
Bolder Surgical, LLC
General & Plastic Surgery · 219d
Cleared Nov 15, 2023
NSite Scoliosis Assessment App
K230463 · LDK
Nsite, Inc.
Physical Medicine · 267d
Cleared Nov 15, 2023
Curing Light, Model: MaxCure 9
K223414 · EBZ
Guilin Refine Medical Instrument Co.,...
Dental · 370d
Cleared Nov 14, 2023
Iconix Anchor
K233468 · MBI
Riverpoint Medical
Orthopedic · 21d
Cleared Nov 14, 2023
Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)
K233434 · LRK
Prismatik Dentalcraft, Inc.
Dental · 32d