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
18313–18336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 2020
AltiVate® Anatomic Pegged Glenoid with Markers
K203026 · KWS
Encore Medical, L.P.
Orthopedic · 82d
Cleared Dec 23, 2020
Omnia Medical TiBrid-SA
K203207 · OVD
Omnia Medical, LLC
Orthopedic · 54d
Cleared Dec 23, 2020
LUBi Water Based Personal Lubricant
K203257 · NUC
Boya Biotechnology Co., Ltd.
Obstetrics & Gynecology · 49d
Cleared Dec 23, 2020
WishBone Medical Plate and Screw System
K203467 · HWC
Wishbone Medical, Inc.
Orthopedic · 28d
Cleared Dec 23, 2020
Bridge Occlusion Balloon
K203540 · MJN
Spectranetics, Inc.
Cardiovascular · 20d
Cleared Dec 22, 2020
SoloAsisst II, Voice Control
K200473 · NAY
Aktormed GmbH
General & Plastic Surgery · 300d
Cleared Dec 22, 2020
iSMILE
K200908 · NXC
3D Diagnostix, Inc.
Dental · 260d
Cleared Dec 22, 2020
PlaniMax Orthodontic Software
K201036 · PNN
Choice Biotech, Inc.
Dental · 246d
Cleared Dec 22, 2020
Impulse Interbody Fusion System
K201287 · MAX
Degen Medical
Orthopedic · 222d
Cleared Dec 22, 2020
Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal...
K201489 · DYB
Argon Medical Devices, Inc.
Cardiovascular · 201d
Cleared Dec 22, 2020
Neodent Implant System - Zirconia Implant System
K201491 · DZE
Jjgc Industria E Comercio DE...
Dental · 201d
Cleared Dec 22, 2020
ChoiceSpine Tiger Shark Cervical Spacer System
K201643 · ODP
Choice Spine, LLC
Orthopedic · 188d
Cleared Dec 22, 2020
ReVene Thrombectomy Catheter
K201705 · QEW
Vetex Medical, Ltd.
Cardiovascular · 183d
Cleared Dec 22, 2020
Opallis, Opallis Flow
K201707 · EBF
Dentscare Ltda
Dental · 183d
Cleared Dec 22, 2020
EZTrack
K201910 · OLX
Neurologic, LLC
Neurology · 166d
Cleared Dec 22, 2020
actiTENS
K202159 · GZJ
Sublimed
Neurology · 141d
Cleared Dec 22, 2020
Disposable Medical Surgical Face Masks
K202211 · FXX
Guangdong Kaidi Garments Co.,Ltd
General Hospital · 138d
Cleared Dec 22, 2020
AI Metrics
K202229 · LLZ
Ai Metrics, LLC
Radiology · 137d
Cleared Dec 22, 2020
Lucent XP, Lucent XP Curved
K202298 · MAX
Spinal Elements, Inc.
Orthopedic · 131d
Cleared Dec 22, 2020
External Remote Controller ERC 4P
K202348 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 126d
Cleared Dec 22, 2020
Australis Anterior Lumbar Cage System
K202820 · MAX
Prism Surgical Designs Pty, Ltd.
Orthopedic · 89d
Cleared Dec 22, 2020
Everyway Analog OTC TENS, model N103A/N302
K202849 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 85d
Cleared Dec 22, 2020
Da Vinci SP Surgical System
K202968 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 83d
Cleared Dec 22, 2020
DenTek Fresh Protect Dental Guard
K202974 · OBR
Medtech Products, Inc.
Dental · 83d