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
8449–8472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 2023
Adravision Perio
K232440 · QIH
Adra Corporation
Radiology · 113d
Cleared Dec 05, 2023
BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit
K232434 · PSZ
Bd
Microbiology · 116d
Cleared Dec 05, 2023
SS Abutment System
K232220 · NHA
Osstem Implant Co., Ltd.
Dental · 132d
Cleared Dec 05, 2023
Liberty SI Lateral Implant System
K231923 · OUR
Spinal Simplicity, LLC
Orthopedic · 158d
Cleared Dec 05, 2023
Disposable Endoscopic Bipolar
K231615 · GEI
Jiangsu Hope Biomedical Science &...
General & Plastic Surgery · 186d
Cleared Dec 05, 2023
Optina-4C (MHRC-C1N)
K231230 · HKI
Optina Diagnostics, Inc.
Ophthalmic · 221d
Cleared Dec 05, 2023
Aurelia Surgical Mask ASTM Level 1
K231005 · FXX
Supermax Healthcare Canada-Supermax...
General Hospital · 242d
Cleared Dec 05, 2023
Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI)...
K230734 · QJF
Precision Healing, LLC
General & Plastic Surgery · 264d
Cleared Dec 05, 2023
Electronic Blood Pressure Monitor, model: HTD6602US
K223170 · DXN
Hetaida Technology Co., Ltd.
Cardiovascular · 420d
Cleared Dec 05, 2023
THERMOCLICK
K222057 · FLL
T&R BIOFAB CO., Ltd.
General Hospital · 511d
Cleared Dec 04, 2023
Verruca-Freeze® H
K233347 · GEH
Cryosurgery, Inc.
General & Plastic Surgery · 66d
Cleared Dec 04, 2023
Intense Pulse Light Therapeutic Apparatus
K232932 · OHT
Shenzhen Greatro Electronic...
General & Plastic Surgery · 75d
Cleared Dec 04, 2023
Tyber Medical Distal Radius Plating System
K232693 · HRS
Tyber Medical, LLC
Orthopedic · 90d
Cleared Dec 04, 2023
Medical Disposable Sterile Needle Electrode
K232581 · GXZ
Suzhou Haishen Medical Device...
Neurology · 101d
Cleared Dec 04, 2023
Monarch Blood Collection Set
K232308 · JKA
The Monarch Company
General Hospital · 124d
Cleared Dec 04, 2023
Maxtec MaxBlend2+p
K231895 · BZR
Maxtec, LLC
Anesthesiology · 159d
Cleared Dec 04, 2023
arcad® 2.0 Duo & Quadro osteosynthesis compressive staples
K230724 · JDR
Novastep
Orthopedic · 263d
Cleared Dec 04, 2023
Access hsTnI
K230648 · MMI
Beckman Coulter, Inc.
Chemistry · 270d
Cleared Dec 04, 2023
cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
K223783 · QWR
Roche Molecular Systems, Inc.
Microbiology · 353d
Cleared Dec 04, 2023
RESPONDER Polysaccharide Hemostat
K220525 · QSY
Starch Medical, Inc.
General & Plastic Surgery · 649d
Cleared Dec 02, 2023
Cosine-10TM Diagnostic Catheter
K233397 · DRF
Medtronic, Inc.
Cardiovascular · 60d
Cleared Dec 01, 2023
BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free...
K233529 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 29d
Cleared Dec 01, 2023
ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories
K233301 · GEX
Lumenis Be, Ltd.
General & Plastic Surgery · 63d
Cleared Dec 01, 2023
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502,...
K233159 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 65d