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
13657–13680 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 2022
Spartan SC 069
K220716 · DQY
Spartan Micro, Inc.
Neurology · 55d
Cleared May 05, 2022
GIA Auto Suture Stapler with DST Series Technology
K221013 · GDW
Covidien
General & Plastic Surgery · 30d
Cleared May 05, 2022
Steriking Packaging for Medical Devices
K221016 · FRG
Wipak OY
General Hospital · 30d
Cleared May 05, 2022
AcQGuide® VUE Steerable Sheath
K221044 · DRA
Acutus Medical, Inc.
Cardiovascular · 27d
Cleared May 05, 2022
Viatrac 14 Plus Peripheral Dilatation Catheter
K221057 · LIT
Abbott Vascular
Cardiovascular · 24d
Cleared May 04, 2022
LiveOne
K201302 · DXN
Livemetric (Medical) S.A.
Cardiovascular · 719d
Cleared May 04, 2022
Plus Medical Chemotherapy Gown
K211036 · FYA
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 392d
Cleared May 04, 2022
BioTeke Sterile Disposable Virus Sampling Kit
K211707 · JSM
Bioteke Corporation (Wuxi) Co., Ltd.
Microbiology · 335d
Cleared May 04, 2022
Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231,...
K212257 · FLL
Alicn Medical (Shenzhen), Inc.
General Hospital · 289d
Cleared May 04, 2022
Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida...
K212588 · DQY
C.R. Bard, Inc.
Cardiovascular · 261d
Cleared May 04, 2022
WaveForm L System, WaveForm TO System, WaveForm TA System
K213420 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 196d
Cleared May 04, 2022
Aurora-RT
K213526 · IYE
Magnettx Oncology Solutions , Ltd.
Radiology · 181d
Cleared May 04, 2022
HydroPICC 5F Dual Lumen Catheter
K213550 · LJS
Access Vascular, Inc.
General Hospital · 177d
Cleared May 04, 2022
ROSA ONE Brain application
K214065 · HAW
Medtech S.A.S
Neurology · 128d
Cleared May 04, 2022
Vista Ophthalmics Vitrectomy Probe
K220030 · MLZ
Vista Ophthalmics, LLC
Ophthalmic · 119d
Cleared May 04, 2022
Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine
K220700 · IZL
Yian Medical Technology (Haining)...
Radiology · 55d
Cleared May 04, 2022
Serranator PTA Serration Balloon Catheter
K220704 · PNO
Cagent Vascular, LLC
Cardiovascular · 55d
Cleared May 04, 2022
MyKnee R Pin Positioners
K220705 · JWH
Medacta International S.A.
Orthopedic · 55d
Cleared May 03, 2022
Orchid Safety Release Valve(TM)
K212064 · QOI
Linear Health Sciences, LLC
General Hospital · 305d
Cleared May 03, 2022
MVision AI Segmentation
K212915 · QKB
MVision AI
Radiology · 232d
Cleared May 03, 2022
exoplan
K213302 · LLZ
Exocad GmbH
Radiology · 211d
Cleared May 03, 2022
ECHOLASER X4
K213594 · GEX
Elesta S.P.A
General & Plastic Surgery · 172d
Cleared May 03, 2022
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS)...
K220013 · JOY
Scopio Labs , Ltd.
Hematology · 119d
Cleared May 03, 2022
ECGenius System
K220306 · DQK
Cath Vision Aps
Cardiovascular · 90d