Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Not cleared only ×
490 results
145–168 of 490
Search insights Median review: 299d Top manufacturer: Biofire Diagnostics, LLC Lead specialty: Microbiology
Not Cleared Feb 17, 2023
PMD-200
DEN210022 · QVE
Medasense Biometrics , Ltd.
Anesthesiology · 623d
Not Cleared Feb 03, 2023
Active Anthrax DetectTM Plus Rapid Test
DEN220044 · QUU
InBios International, Inc.
Microbiology · 210d
Not Cleared Feb 01, 2023
RefleXion Medical Radiotherapy System (RMRS)
DEN220014 · QVA
Reflexion Medical, Inc.
Radiology · 343d
Not Cleared Dec 23, 2022
BioXmark
DEN220017 · QUV
Nanovi A/S
Radiology · 294d
Not Cleared Dec 16, 2022
Tornier Pyrocarbon Humeral Head
DEN220012 · QKW
Tornier S.A.S.
Orthopedic · 311d
Not Cleared Nov 09, 2022
Eonis SCID-SMA Kit
DEN200044 · QUE
Perkinelmer, Inc.
Medical Genetics · 854d
Not Cleared Oct 18, 2022
ScanNav Anatomy Peripheral Nerve Block
DEN220024 · QRG
Intelligent Ultrasound Limited
Anesthesiology · 193d
Not Cleared Oct 14, 2022
The Cooral System
DEN210027 · QUA
Braincool AB
Dental · 469d
Not Cleared Sep 29, 2022
INNOVANCE VWF Ac
DEN200067 · QTY
Siemens Healthcare Diagnostics...
Hematology · 701d
Not Cleared Sep 16, 2022
Phagenyx System
DEN220025 · QQG
Phagenesis Limited
Ear, Nose, Throat · 150d
Not Cleared Aug 26, 2022
Vibrant System
DEN210052 · QTN
Vibrant, Ltd.
Gastroenterology & Urology · 269d
Not Cleared Jul 26, 2022
AccuMeasure System
DEN210032 · QTH
RQMIS, Inc.
Gastroenterology & Urology · 351d
Not Cleared Jul 12, 2022
APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE...
DEN210045 · QTD
Apollo Endosurgery, Inc.
Gastroenterology & Urology · 285d
Not Cleared Jun 17, 2022
Zuno Smart Sterilization Container
DEN210004 · QJT
Zuno Medical, Inc.
General Hospital · 486d
Not Cleared Jun 13, 2022
ProdiGI
DEN220006 · QSW
Covidien, LLC
Gastroenterology & Urology · 150d
Not Cleared May 24, 2022
Parsortix PC1 Device
DEN200062 · QSA
Angle Europe , Ltd.
Medical Genetics · 603d
Not Cleared May 18, 2022
Quell-FM
DEN210046 · QSQ
Neurometrix, Inc.
Neurology · 225d
Not Cleared May 17, 2022
CERAMENT G
DEN210044 · QRR
Bonesupport AB
Orthopedic · 231d
Not Cleared May 04, 2022
Lumipulse G ß-Amyloid Ratio (1-42/1-40)
DEN200072 · QSE
Fujirebio Diagnostics,Inc.
Immunology · 530d
Not Cleared May 02, 2022
Kerasave
DEN200063 · QCW
Al.Chi.Mi.A. S.R.L
Ophthalmic · 578d
Not Cleared Apr 29, 2022
BioFire Joint Infection (JI) Panel
DEN200066 · QSN
Biofire Diagnostics, LLC
Microbiology · 549d
Not Cleared Mar 29, 2022
BrainTemp Neonate System (BTNeo System)
DEN200042 · QSL
Brain Temp, Inc.
Neurology · 644d
Not Cleared Feb 23, 2022
ONE Male Condom
DEN210034 · QRZ
Global Protection Corp.
Obstetrics & Gynecology · 181d
Not Cleared Jan 21, 2022
POMC/PCSK1/LEPR CDx Panel
DEN200059 · QRV
Preventiongenetics, LLC
Chemistry · 490d