FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
18937–18960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 2020
Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation...
K192703 · HAW
Brainlab AG
Neurology · 377d
Cleared Oct 08, 2020
Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22
K193542 · KDI
Bellco Srl
Gastroenterology & Urology · 293d
Cleared Oct 08, 2020
Steripath Micro Blood Collection System
K200661 · FPA
Magnolia Medical Technologies, Inc.
General Hospital · 210d
Cleared Oct 08, 2020
SilverStream Gel
K200767 · FRO
Enzysurge , Ltd.
General & Plastic Surgery · 197d
Cleared Oct 08, 2020
LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical...
K200793 · NKG
L & K Biomed Co., Ltd.
Orthopedic · 196d
Cleared Oct 08, 2020
IPS CaseDesigner
K200810 · LLZ
Nobel Biocare AB
Radiology · 195d
Cleared Oct 08, 2020
Impression Material
K201483 · ELW
Zhengzhou Huaer Electro Optics...
Dental · 126d
Cleared Oct 08, 2020
ECG App
K201525 · QDA
Apple, Inc.
Cardiovascular · 122d
Cleared Oct 08, 2020
31HN713D
K201777 · PGY
Lg Electronics.Inc
Radiology · 101d
Cleared Oct 08, 2020
Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
K201845 · NGX
Guangzhou Longest Science &...
Neurology · 94d
Cleared Oct 08, 2020
Piccolo Composite Proximal Tibia Plate System
K201917 · HRS
CarboFix Orthopedics , Ltd.
Orthopedic · 90d
Cleared Oct 08, 2020
GAIA Lumbar Interbody Fusion Device (LIFD) Family
K201939 · MAX
Printerprezz
Orthopedic · 87d
Cleared Oct 08, 2020
Schoelly Cystoscopes/Hysteroscopes and Accessories
K201970 · HIH
Schoelly Fiberoptic GmbH
Obstetrics & Gynecology · 85d
Cleared Oct 08, 2020
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1
K201972 · IYN
Canon Medical Systems Corporation
Radiology · 85d
Cleared Oct 08, 2020
Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation...
K202309 · KWQ
Zimmer Biomet Spine, Inc.
Orthopedic · 55d
Cleared Oct 08, 2020
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy...
K202478 · FDI
Boston Scientific Corporation
Gastroenterology & Urology · 41d
Cleared Oct 08, 2020
Adavanced Imaging Modality System (1688 4K Camera System With Advanced...
K202592 · GCJ
Stryker
General & Plastic Surgery · 30d
Cleared Oct 07, 2020
Flower Suture Anchor Set
K192949 · MBI
Flower Orthopedics Corporation
Orthopedic · 355d
Cleared Oct 07, 2020
Abutment Design
K200100 · PNP
3Shape A/S
Dental · 265d
Cleared Oct 07, 2020
Citregen Tendon Interference Screw and Citrelock
K200725 · MAI
Acuitive Technologies
Orthopedic · 202d
Cleared Oct 07, 2020
Infrared Thermometer
K200802 · FLL
Shenzhen Urion Technology Co., Ltd.
General Hospital · 194d
Cleared Oct 07, 2020
URIS OMNI Narrow System & Prosthetic
K200817 · DZE
Truabutment, Inc.
Dental · 191d
Cleared Oct 07, 2020
Livocare Surgical Mask
K201380 · FXX
Andon Health Co, Ltd.
General Hospital · 134d
Cleared Oct 07, 2020
Fortilink Cages with TiPlus Technology
K201453 · MAX
Paradigm Spine GmbH
Orthopedic · 128d