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
13009–13032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 2022
Digital Radiography CXDI-Elite, Digital Radiography E1
K221620 · MQB
Canon, Inc.
Radiology · 11d
Cleared Jun 13, 2022
Disposable Hemostatic Closure Clip Device
K220157 · PKL
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 145d
Cleared Jun 13, 2022
iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System
K221081 · IZL
First Source, Inc.
Radiology · 62d
Cleared Jun 13, 2022
3M Filtek Supreme Flowable Restorative
K221695 · EBF
3M Company Espe Dental Products
Dental · 3d
Cleared Jun 12, 2022
Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System
K203208 · DQA
Taiwan Aulisa Medical Devices...
Anesthesiology · 590d
Cleared Jun 11, 2022
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
K221384 · NUH
Hivox Biotek, Inc.
Neurology · 29d
Cleared Jun 10, 2022
Elecsys AMH
K203757 · PQO
Roche Diagnostics
Chemistry · 534d
Cleared Jun 10, 2022
EasyClip® and EasyClip® Xpress
K210582 · JDR
Stryker GmbH
Orthopedic · 469d
Cleared Jun 10, 2022
PAL System
K212024 · QPB
Microaire Surgical Instruments, LLC
General & Plastic Surgery · 346d
Cleared Jun 10, 2022
Armory Motion
K213097 · ILO
Pain Management Technologies, Inc.
Neurology · 259d
Cleared Jun 10, 2022
Extroducer Infusion Catheter System
K213442 · KRA
SmartWise Sweden AB
Cardiovascular · 228d
Cleared Jun 10, 2022
WesperO2
K213515 · DQA
Wesper, Inc.
Anesthesiology · 220d
Cleared Jun 10, 2022
Rune Labs Tremor Transducer System
K213519 · GYD
Rune Labs, Inc.
Neurology · 219d
Cleared Jun 10, 2022
iFuse-TORQ® Implant System
K213667 · OUR
SI-BONE, Inc.
Orthopedic · 200d
Cleared Jun 10, 2022
Pre-filled Syringe with Saline
K220060 · NGT
Jiangsu Caina Medical Co.,Ltd
General Hospital · 151d
Cleared Jun 10, 2022
Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System
K220319 · HWC
Stryker GmbH
Orthopedic · 127d
Cleared Jun 10, 2022
Saffron Fixation System
K220420 · PBQ
Coloplast A/S
Obstetrics & Gynecology · 116d
Cleared Jun 10, 2022
Surgical Isolation Cover Gown
K220528 · FYC
Wuhan Dymex Healthcare Co., Ltd.
General Hospital · 106d
Cleared Jun 10, 2022
IntellaMap Orion High Resolution Mapping Catheter
K220796 · DRF
Boston Scientific Corporation
Cardiovascular · 84d
Cleared Jun 10, 2022
SmileGuard
K220894 · MQC
Envisiontec GmbH
Dental · 74d
Cleared Jun 10, 2022
MediLab
K221065 · LLZ
Sigma Scientific Services, LLC
Radiology · 59d
Cleared Jun 10, 2022
Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
K221087 · HAW
Medtronic Navigation, Inc.
Neurology · 58d
Cleared Jun 10, 2022
Omni Foot and Ankle Plating System
K221362 · HRS
Exremity Medical, LLC
Orthopedic · 30d
Cleared Jun 10, 2022
Nalu Neurostimulation System
K221376 · GZB
Boston Scientific Neuromodulation
Neurology · 29d