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

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175,820 results
7057–7080 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 26, 2024
Introcan Safety® 2 IV Catheter
K241845 · FOZ
B.Braun Medical, Inc.
General Hospital · 30d
Cleared Jul 26, 2024
Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
K241800 · MRR
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 26, 2024
NEXA™ NPWT System
K241515 · OMP
Nexa Medical Limited
General & Plastic Surgery · 58d
Cleared Jul 26, 2024
Pantheon Pedicle Screw and Iliac Bolt Fixation System
K241494 · NKB
Pantheon Spinal
Orthopedic · 59d
Cleared Jul 26, 2024
Alien Aligners
K241187 · NXC
Alien Milling Technologies
Dental · 88d
Cleared Jul 26, 2024
Tandem Mobi Insulin Pump with interoperable technology
K241078 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 98d
Cleared Jul 26, 2024
Luja female (20051)
K241028 · EZD
Coloplast
Gastroenterology & Urology · 102d
Cleared Jul 26, 2024
STAR Apollo™ Mapping System
K240509 · DQK
Rhythm AI, Ltd.
Cardiovascular · 155d
Cleared Jul 26, 2024
ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001,...
K240401 · HIH
Origyn Medical Technology (Hangzhou)...
Obstetrics & Gynecology · 168d
Cleared Jul 26, 2024
Accusafe Transseptal Guidewire (GTR31180, GTR31230)
K240246 · DRC
Synaptic Medical Corporation
Cardiovascular · 178d