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
12745–12768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 2022
Benchmark BMX96 Access System
K213390 · QJP
Penumbra, Inc.
Neurology · 307d
Cleared Aug 18, 2022
GuideLiner Coast, 5.5F (5270)
K220647 · DQY
Vascular Solutions, LLC
Cardiovascular · 164d
Cleared Aug 18, 2022
OR3O Dual Mobility System
K220959 · LPH
Smith & Nephew, Inc.
Orthopedic · 139d
Cleared Aug 18, 2022
EnSite X EP System
K221213 · DQK
Abbott
Cardiovascular · 113d
Cleared Aug 18, 2022
Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen...
K221353 · DWF
Qura S.R.L
Cardiovascular · 100d
Cleared Aug 18, 2022
Miro3D Wound Matrix
K221520 · KGN
Reprise Biomedical, Inc.
General & Plastic Surgery · 85d
Cleared Aug 18, 2022
truFreeze Console, PN CC301
K222272 · GEH
STERIS Corporation
General & Plastic Surgery · 20d
Cleared Aug 17, 2022
implaFit® hip stems
K210678 · LZO
Implantcast GmbH
Orthopedic · 530d
Cleared Aug 17, 2022
Disposable Sterile Syringe, with/without needle
K212033 · FMF
Shandong Zhushi Pharmaceutical Group...
General Hospital · 414d
Cleared Aug 17, 2022
Cross Protection ResQ300 Plus Surgical Face Mask
K212273 · FXX
Cross Protection (M) Sdn Bhd
General Hospital · 393d
Cleared Aug 17, 2022
Disposable Blood Lancets
K220387 · QRL
Suzhou Kyuan Medical Apparatus Co., Ltd.
General & Plastic Surgery · 188d
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