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
6457–6480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 2024
Silverlon® Wound Contact, Burn Contact Dressing
K241225 · FRO
Argentum Medical, LLC
General & Plastic Surgery · 90d
Cleared Jul 31, 2024
ValvuloPro Valvuloplasty Balloon Catheter
K240967 · OZT
Dongguan TT Medical, Inc.
Cardiovascular · 113d
Cleared Jul 31, 2024
SteriTite rigid reusable sterilization container with MediTray Products
K240898 · KCT
Case Medical
General Hospital · 121d
Cleared Jul 31, 2024
VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava...
K240578 · DTK
B.Braun Medical, Inc.
Cardiovascular · 152d
Cleared Jul 31, 2024
LW Narrow Implant System
K233808 · DZE
Ossvis Co., Ltd.
Dental · 244d
Cleared Jul 31, 2024
AF531 Oro-Nasal EE Leak 1 Face Mask
K233555 · BZD
Philips Respironics
Anesthesiology · 268d
Cleared Jul 31, 2024
ARCHITECT Active-B12 (Holotranscobalamin)
K233541 · CDD
Axis-Shield Diagnostics, Ltd.
Chemistry · 271d
Cleared Jul 30, 2024
WERAY
K241963 · EHD
Picopack Co., Ltd.
Radiology · 27d
Cleared Jul 30, 2024
Activmotion S
K241539 · HRS
Newclip Technics
Orthopedic · 60d
Cleared Jul 30, 2024
SmartShape™ Healing Abutment
K240531 · NHA
BioHorizons Implant Systems, Inc.
Dental · 158d
Cleared Jul 30, 2024
Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx,...
K240446 · KIF
Shiva Products
Dental · 166d
Cleared Jul 30, 2024
Nano-Check™ RSV Test
K240280 · GQG
Nano-Ditech Corporation
Microbiology · 180d
Cleared Jul 29, 2024
Montage Settable Bone Putty
K242050 · MQV
Orthocon, Inc.
Orthopedic · 17d
Cleared Jul 29, 2024
BIOCHARGE
K241912 · MAI
Nanofiber Solutions, LLC
Orthopedic · 28d
Cleared Jul 29, 2024
BioBrace® Reinforced Implant
K241906 · OWW
Conmed Corporation
Orthopedic · 28d
Cleared Jul 29, 2024
ARx® SAI Implant System
K241464 · OUR
Life Spine, Inc.
Orthopedic · 67d
Cleared Jul 29, 2024
EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)
K241209 · FCG
Cook Ireland, Ltd.
Gastroenterology & Urology · 90d
Cleared Jul 29, 2024
PowerGlide Pro™ Midline Catheter
K240359 · FOZ
Becton, Dickinson and Company (Bard...
General Hospital · 174d
Cleared Jul 29, 2024
Solar™ Lumbar Interbody Fusion System
K240326 · MAX
Degen Medical, Inc.
Orthopedic · 178d
Cleared Jul 29, 2024
AtriClip FLEX-Mini LAA Exclusion System (ACHM)
K234125 · PZX
AtriCure, Inc.
Cardiovascular · 214d
Cleared Jul 29, 2024
Medical surgical mask
K233723 · FXX
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 251d
Cleared Jul 26, 2024
Symbia SPECT and SPECT/CT Systems
K241898 · KPS
Siemens Healthineers
Radiology · 28d
Cleared Jul 26, 2024
DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00)
K241883 · HBL
Pro-Med Instruments GmbH
Neurology · 28d
Cleared Jul 26, 2024
InnovaMatrix®FD
K241866 · KGN
Convatec Triad Life Sciences, LLC
General & Plastic Surgery · 29d