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
13153–13176 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 2022
CLAROX
K221286 · EHD
Vsi Co., Ltd.
Radiology · 57d
Cleared Jun 29, 2022
Diode Laser Hair Removal Device
K221312 · GEX
Guangzhou Chuang Zao Mei Technology...
General & Plastic Surgery · 55d
Cleared Jun 29, 2022
780 nm L11 LED Light Source with AIM
K221611 · OWN
Stryker
General & Plastic Surgery · 26d
Cleared Jun 29, 2022
Flat Panel Detector
K221714 · MQB
Iray Technology Taicang , Ltd.
Radiology · 16d
Cleared Jun 28, 2022
Patient Specific Marking Guides
K211076 · PBF
Additive Orthopaedics, LLC
Orthopedic · 442d
Cleared Jun 28, 2022
3M Attest Rapid Readout Biological Indicator, 1295
K211705 · FRC
3M Company
General Hospital · 390d
Cleared Jun 28, 2022
Venus Cervical Plate System
K211718 · KWQ
Artfx Medical, LLC
Orthopedic · 389d
Cleared Jun 28, 2022
BD Pen Needle
K213478 · FMI
Becton, Dickinson and Company
General Hospital · 242d
Cleared Jun 28, 2022
VenAir, Sequential Compression System
K213577 · JOW
Apex Medical Corp.
Cardiovascular · 230d
Cleared Jun 28, 2022
PL-1 Skin Treatment System
K213726 · GEX
Avava, Inc.
General & Plastic Surgery · 214d
Cleared Jun 28, 2022
Med-link Disposable ECG Cable and Leadwires
K220447 · DSA
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 132d
Cleared Jun 28, 2022
DePuy CONDUIT LLIF SQUID Inserter
K220449 · MAX
Enztec Limited
Orthopedic · 132d
Cleared Jun 28, 2022
Magnum
K220670 · FXX
Magnum Health and Safety Pvt, Ltd.
General Hospital · 113d
Cleared Jun 28, 2022
OsteoProbe
K221195 · QGQ
Active Life Scientific, Inc.
Orthopedic · 64d
Cleared Jun 28, 2022
Mg OSTEOINJECT
K221256 · MQV
Bone Solutions, Inc.
Orthopedic · 57d
Cleared Jun 28, 2022
Medical Face Mask
K221272 · FXX
Shandong Xingyu Gloves Co., Ltd.
General Hospital · 57d
Cleared Jun 28, 2022
Medical Face Mask (M001)
K221273 · FXX
Xingyu Medical Tech Co., Ltd.
General Hospital · 57d
Cleared Jun 27, 2022
Navident
K210947 · PLV
Claronav, Inc.
Dental · 454d
Cleared Jun 27, 2022
CiRX Single use electrosurgical pencil with non-coated and coated electrode
K213786 · GEI
Ningbo Shun YE Medical Company, Ltd.
General & Plastic Surgery · 203d
Cleared Jun 27, 2022
VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal...
K213818 · GCJ
Covidien
General & Plastic Surgery · 202d
Cleared Jun 27, 2022
Wearable Breast Pump (Model S10)
K220309 · HGX
Shenzhen Lutejiacheng Technology Co.,...
Obstetrics & Gynecology · 145d
Cleared Jun 27, 2022
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare
K220790 · FDI
Yangzhou Fartley Medical Instrument...
Gastroenterology & Urology · 102d
Cleared Jun 27, 2022
Venue Fit
K220848 · IYN
GE Medical Systems
Radiology · 96d
Cleared Jun 27, 2022
Venue
K220851 · IYN
GE Medical Systems
Radiology · 96d