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
10849–10872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2023
HPR45i
K220725 · GEI
F Care Systems USA, LLC
General & Plastic Surgery · 371d
Cleared Mar 20, 2023
P-Cure Proton Beam Therapy System
K221996 · LHN
P-Cure, Ltd.
Radiology · 257d
Cleared Mar 20, 2023
Atellica® CH Diazo Total Bilirubin (D_TBil)
K222104 · CIG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 245d
Cleared Mar 20, 2023
Shina Safety Needle
K222417 · FMI
Shina Corporation
General Hospital · 222d
Cleared Mar 20, 2023
Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B,...
K222828 · GCJ
Wickimed (Huizhou) Medical Equipment...
General & Plastic Surgery · 182d
Cleared Mar 20, 2023
The Integrity Spine Core System
K223043 · ODP
Integrity Spine
Orthopedic · 179d
Cleared Mar 20, 2023
Colibrí
K223245 · QQV
Copan Wasp Srl
Microbiology · 151d
Cleared Mar 20, 2023
MOBINEURO Alita Intraoperative MRI System
K223875 · LNH
Sino Canada Health Engineering...
Radiology · 87d
Cleared Mar 20, 2023
TENS and EMS Stimulation (OTC)
K230163 · NUH
Changsha Yuwen Medical Equipment Co.,...
Physical Medicine · 59d
Cleared Mar 20, 2023
TENS and EMS Stimulation (OTC)
K230174 · NUH
Changsha Yuwen Medical Equipment Co.,...
Physical Medicine · 59d
Cleared Mar 18, 2023
InterOss Collagen
K221808 · NPM
Sigmagraft, Inc.
Dental · 269d
Cleared Mar 18, 2023
EOlife®
K221841 · BTM
Archeon
Anesthesiology · 267d
Cleared Mar 17, 2023
Simplexa COVID-19 & Flu A/B Direct
K220963 · QOF
Diasorin Molecular, LLC
Microbiology · 350d
Cleared Mar 17, 2023
RCRP Flex reagent cartridge
K221119 · DCN
Siemens Healthcare Diagnostics, Inc.
Immunology · 333d
Cleared Mar 17, 2023
MagVenture TMS Atlas Neuro Navigation System
K221544 · HAW
Tonica Elektronik A/S
Neurology · 294d
Cleared Mar 17, 2023
SMR Stemless Anatomic
K221758 · PKC
Lima Corporate S.P.A.
Orthopedic · 274d
Cleared Mar 17, 2023
NeuroRPM
K221772 · GYD
New Touch Digital, Inc.
Neurology · 269d
Cleared Mar 17, 2023
Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
K221782 · DRS
Merit Medical Pte. , Ltd.
Cardiovascular · 269d
Cleared Mar 17, 2023
KARL STORZ Bipolar Resectoscopes with HF Cable
K221893 · FJL
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 261d
Cleared Mar 17, 2023
FemDx FalloView
K221965 · MKO
Femdx Medsystems, Inc.
Obstetrics & Gynecology · 255d
Cleared Mar 17, 2023
Prism
K222101 · HCC
Graymatters Health , Ltd.
Neurology · 242d
Cleared Mar 17, 2023
Alio
K223073 · DRG
Alio, Inc.
Gastroenterology & Urology · 168d
Cleared Mar 17, 2023
Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug...
K223162 · LDJ
Healgen Scientific, LLC
Toxicology · 161d
Cleared Mar 17, 2023
DeGen Impulse AM™ System
K223418 · MAX
Degen Medical
Orthopedic · 127d