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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Not cleared only ×
487 results
145–168 of 487
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
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
Not Cleared Jan 07, 2022
Sunrise Sleep Disorder Diagnostic Aid
DEN210015 · QRS
Sunrise
Anesthesiology · 280d
Not Cleared Dec 21, 2021
CavaClear Laser Sheath
DEN210024 · QRJ
Spectranetics, Inc.
Cardiovascular · 179d
Not Cleared Dec 10, 2021
Comfort Marker 2.0.
DEN200041 · QRN
Medical Precision BV
Radiology · 536d