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
13201–13224 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 2022
Medline General Surgery Tray
K213481 · LRO
Medline Industries, Inc.
General & Plastic Surgery · 207d
Cleared May 24, 2022
LigaPASS™ 2.0 Ligament Augmentation System
K213659 · OWI
Medicrea International SA
Orthopedic · 186d
Cleared May 24, 2022
Disposable Face Mask
K220191 · FXX
Jiujiang Taixin Technology Co., Ltd.
General Hospital · 120d
Cleared May 24, 2022
MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides
K220888 · QSR
Medacta International S.A.
Orthopedic · 57d
Cleared May 24, 2022
MY01 Continuous Compartmental Pressure Monitor
K220952 · LXC
MY01, Inc.
Orthopedic · 53d
Cleared May 24, 2022
e-motion M25
K221215 · ITI
Alber GmbH
Physical Medicine · 27d
Cleared May 23, 2022
Assure Titanium Blood Glucose Monitoring System
K200788 · PZI
Arkray, Inc.
Chemistry · 788d
Cleared May 23, 2022
Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with...
K211810 · LZA
Pt. Shamrock Manufacturing Corpora
General Hospital · 346d
Cleared May 23, 2022
LiquiBand XL
K211878 · OMD
Advanced Medical Solutions Limited
General & Plastic Surgery · 336d
Cleared May 23, 2022
CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical...
K212563 · KIF
Prevest Denpro Limited
Dental · 283d
Cleared May 23, 2022
DailyMate Orthodontic Aligner System
K212803 · NXC
3D Global Biotech, Inc.
Dental · 263d
Cleared May 23, 2022
ONO Retrieval Device
K212988 · MMX
Onocor Vascular, LLC
Cardiovascular · 245d
Cleared May 23, 2022
Triever24, Triever20
K213402 · QEW
Inari Medical
Cardiovascular · 217d
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