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
13489–13512 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2022
SCENARIA View
K213829 · JAK
Fujifilm Healthcare Corporation
Radiology · 166d
Cleared May 23, 2022
Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
K220155 · LZA
Motex Healthcare (Anhui) Co., Ltd.
General Hospital · 124d
Cleared May 23, 2022
Smart Wireless Stethoscope
K220470 · DQD
Shanghai Hulu Devices Co., Ltd.
Cardiovascular · 94d
Cleared May 23, 2022
3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large
K220507 · PZW
3M Company
General Hospital · 90d
Cleared May 23, 2022
Disposable surgical mask
K220532 · FXX
Xiamen Blue Star Enterprise Co., Ltd.
General Hospital · 88d
Cleared May 23, 2022
3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam...
K220564 · JOJ
3M Company
General Hospital · 84d
Cleared May 23, 2022
Tapestry Biointegrative Implant
K220867 · OWY
Embody, Inc.
Orthopedic · 59d
Cleared May 23, 2022
ON3D
K221000 · LLZ
3D Ons, Inc.
Radiology · 49d
Cleared May 20, 2022
Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light...
K210545 · OLP
Marci Beauty, Inc.
General & Plastic Surgery · 449d
Cleared May 20, 2022
Disposable Sampler Viral Transport Media
K211256 · JSM
Wuxi Nest Biotechnology Co., Ltd.
Microbiology · 389d
Cleared May 20, 2022
Med-link Pulse Oximeter
K212752 · DQA
Shenzhen Med-Link Electronics Tech...
Anesthesiology · 263d
Cleared May 20, 2022
CalcShift™ Displacement Calcaneal Osteotomy System
K212979 · HRS
Nextremity Solutions, Inc.
Orthopedic · 245d
Cleared May 20, 2022
Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set
K213540 · DWF
Qura S.R.L
Cardiovascular · 193d
Cleared May 20, 2022
Diode Laser Therapy Systems
K220381 · GEX
Beijing Lasertell Medical Co., Ltd.
General & Plastic Surgery · 99d
Cleared May 20, 2022
7D Surgical System - Percutaneous Application (7D Flash Frame)
K220522 · OLO
7D Surgical
Orthopedic · 86d
Cleared May 20, 2022
iovera System
K220656 · GXH
Pacira Biosciences, Inc.
Neurology · 74d
Cleared May 20, 2022
syngo Dynamics (Version VA40E)
K220832 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 59d
Cleared May 20, 2022
Artisan Bone Plug, Universal Cement Restrictor
K220838 · LZN
Howmedica Osteonics, Dba Stryker...
Orthopedic · 59d
Cleared May 19, 2022
Alinity i STAT High Sensitivity Troponin-I
K202525 · MMI
Abbott Laboratories Diagnostics Division
Chemistry · 625d
Cleared May 19, 2022
ARCHITECT Toxo IgG
K210596 · LGD
Abbott Laboratories
Microbiology · 444d
Cleared May 19, 2022
BD Epilor Syringe
K210983 · CAZ
Becton, Dickinson and Company
Anesthesiology · 413d
Cleared May 19, 2022
RevoLix HTL
K211534 · GEX
Lisa Laser Products GmbH
Gastroenterology & Urology · 366d
Cleared May 19, 2022
OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A...
K211869 · LOD
Ormed Grup Medikal Turizm Saglik...
Orthopedic · 337d
Cleared May 19, 2022
CoverScan v1
K212565 · LLZ
Perspectum, Ltd.
Radiology · 279d