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
12481–12504 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 2022
Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase...
K220452 · QHE
Materialise NV
Orthopedic · 181d
Cleared Aug 17, 2022
Tetragraph Neuromuscular Transmission Monitor
K220530 · KOI
Senzime AB
Anesthesiology · 174d
Cleared Aug 17, 2022
Disposable Brain Biopsy Needle 2.0
K220897 · HAW
PAJUNK GmbH Medizintechnologie
Neurology · 142d
Cleared Aug 17, 2022
WebCeph
K220903 · LLZ
Assemblecircle Corp.
Radiology · 142d
Cleared Aug 17, 2022
CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)
K221112 · DQK
Biosense Webster, Inc.
Cardiovascular · 124d
Cleared Aug 17, 2022
Surgical Face Mask (HNFM0103)
K221838 · FXX
Shanghai Hua EN Industrial Co, Ltd.
General Hospital · 55d
Cleared Aug 17, 2022
TDM Lumbar Interbody Fusion Cage System
K221844 · MAX
Tdm Co., Ltd.
Orthopedic · 54d
Cleared Aug 16, 2022
YUWELL Finger Pulse Oximeter
K212385 · DQA
Jiangsu Yuyue Medical Equipment&...
Anesthesiology · 379d
Cleared Aug 16, 2022
Clear Aligner
K213026 · NXC
Shenzhen Meiming Dentistry Technology...
Dental · 329d
Cleared Aug 16, 2022
HemosIL ReadiPlasTin
K213426 · GJS
Instrumentation Laboratory CO
Hematology · 299d
Cleared Aug 16, 2022
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves...
K213937 · LZA
O&M Halyard, Inc.
General Hospital · 243d
Cleared Aug 16, 2022
G-CAM
K220329 · EBF
Graphenano Dental S.L.
Dental · 193d
Cleared Aug 16, 2022
syngo Application Software (VE21)
K220433 · LLZ
Siemens Medical Solution USA, Inc.
Radiology · 182d
Cleared Aug 16, 2022
ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select...
K221190 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 113d
Cleared Aug 16, 2022
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6...
K221852 · PPN
Shockwave Medical, Inc.
Cardiovascular · 50d
Cleared Aug 16, 2022
FairFix Adjustable Button System
K222169 · MBI
Medacta International S.A.
Orthopedic · 26d
Cleared Aug 15, 2022
XLase Plus
K212790 · GEX
Biotec Italia, Srl
General & Plastic Surgery · 348d
Cleared Aug 15, 2022
FORUM
K213527 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 284d
Cleared Aug 15, 2022
HeRO Graft
K213845 · DSY
Merit Medical Systems, Inc.
Cardiovascular · 249d
Cleared Aug 15, 2022
da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
K214095 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 230d
Cleared Aug 15, 2022
Her-2, ER, PR IHControls
K220163 · NJW
Boston Cell Standards, Inc.
Pathology · 207d
Cleared Aug 15, 2022
Recon Steerable Sheath
K221302 · EOQ
Serpex Medical, Inc.
Ear, Nose, Throat · 102d
Cleared Aug 12, 2022
ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion...
K202461 · LGZ
Smisson-Cartledge Biomedical, LLC
General Hospital · 715d
Cleared Aug 12, 2022
Hemo-Lyte C Cartridge
K202508 · KPO
Di-Chem, Inc.
Gastroenterology & Urology · 711d