FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
8161–8184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 2023
Sterile Nitrile Examination Gloves Powder Free Tested for Use with...
K233042 · LZA
Shandong Intco Medical Products Co, Ltd.
General Hospital · 72d
Cleared Dec 06, 2023
BeaMed Laser Surgery Fibers
K232769 · GEX
Bt Beamedical Tachnoogies Ltd. (Beamed)
General & Plastic Surgery · 86d
Cleared Dec 06, 2023
SOMATOM Pro.Pulse
K232206 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 134d
Cleared Dec 06, 2023
OneRF Ablation System
K231675 · GXD
Neuroone Medical Technologies Corp.
Neurology · 181d
Cleared Dec 06, 2023
Q-Pad Test System
K231465 · LCP
Qurasense
Chemistry · 201d
Cleared Dec 06, 2023
2008T BlueStar Hemodialysis Machine
K231125 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 230d
Cleared Dec 06, 2023
SG Lanset I, SG Lancets, Soft Lancets
K230712 · QRK
Sewon Medical Co.
General & Plastic Surgery · 266d
Cleared Dec 06, 2023
Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)
K230677 · OMP
Cork Medical
General & Plastic Surgery · 271d
Cleared Dec 06, 2023
Evolve Nitric Oxide Delivery System
K222930 · MRN
Mallinckrodt Manufacturing, LLC
Anesthesiology · 436d
Cleared Dec 05, 2023
Ceevra Reveal 3+
K233568 · QIH
Ceevra, Inc.
Radiology · 29d
Cleared Dec 05, 2023
SIGNAFUSE Bioactive Strip (SBS)
K233490 · MQV
Bioventus, LLC
Orthopedic · 39d
Cleared Dec 05, 2023
Tablo® Hemodialysis System
K233335 · KDI
Outset Medical, Inc.
Gastroenterology & Urology · 67d
Cleared Dec 05, 2023
Electronic Blood Pressure Monitor
K232814 · DXN
Zhuhai Yueja Medical Device...
Cardiovascular · 83d
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