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
73–96 of 490
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Jul 15, 2024
Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa...
DEN230092 · SBT
Diasorin Molecular, LLC
Microbiology · 200d
Not Cleared Jul 12, 2024
Terragene Bionova Photon Biological Indicator (BT225)
DEN220042 · QVB
Terragene S.A.
General Hospital · 742d
Not Cleared Jul 02, 2024
MagDI System
DEN240013 · SAH
Gt Metabolic Solutions, Inc.
General & Plastic Surgery · 98d
Not Cleared Jul 01, 2024
BioHealx Anal Fistula Device
DEN240007 · QML
Signum Surgical Limited
General & Plastic Surgery · 150d
Not Cleared Jun 27, 2024
FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System
DEN230055 · QQJ
Balance Ophthalmics, Inc.
Ophthalmic · 307d
Not Cleared Jun 27, 2024
Xpert HCV
DEN240016 · SBP
Cepheid
Microbiology · 72d
Not Cleared Jun 11, 2024
Mi-CHORD System
DEN230069 · SBK
Lsi Solutions, Inc.
Cardiovascular · 256d
Not Cleared May 21, 2024
3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder...
DEN230068 · JOJ
3M Company
General Hospital · 235d
Not Cleared May 17, 2024
DentalMonitoring
DEN230035 · SBC
Dental Monitoring Sas
Dental · 379d
Not Cleared May 15, 2024
Notal Vision Home Optical Coherence Tomography (OCT) System
DEN230043 · SAX
Notal Vision, Inc.
Ophthalmic · 343d
Not Cleared Apr 29, 2024
Eversense AP CGM System
DEN230052 · SBA
Senseonics, Incorporated
Chemistry · 264d
Not Cleared Apr 09, 2024
Rho
DEN230023 · SAO
16 Bit, Inc.
Radiology · 372d
Not Cleared Apr 05, 2024
ELEOSx™ Limb Salvage System
DEN210058 · QZZ
Onkos Surgical
Orthopedic · 827d
Not Cleared Apr 05, 2024
Orthobond Mariner Pedicle Screw System
DEN220015 · QZY
Orthobond Coporation
Orthopedic · 767d
Not Cleared Apr 05, 2024
Symani Surgical System
DEN230032 · SAQ
Mmi North America, Inc.
General & Plastic Surgery · 346d
Not Cleared Apr 02, 2024
Sepsis ImmunoScore
DEN230036 · SAK
Prenosis, Inc.
Gastroenterology & Urology · 333d
Not Cleared Mar 27, 2024
Medline ART Skin Harvesting System
DEN210049 · QYK
Medline Industries, Inc.
General & Plastic Surgery · 890d
Not Cleared Mar 22, 2024
X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with...
DEN230034 · SAL
Scopio Labs , Ltd.
Hematology · 329d
Not Cleared Feb 28, 2024
Technozym ADAMTS13 Activity
DEN230024 · SAC
Technoclone Herstellung Von...
Hematology · 328d
Not Cleared Feb 23, 2024
MIRA Surgical System
DEN230025 · SAB
Virtual Incision
General & Plastic Surgery · 318d
Not Cleared Feb 21, 2024
BraidE Embolization Assist Device
DEN230064 · QZU
Rapid Medical , Ltd.
Cardiovascular · 155d
Not Cleared Feb 06, 2024
Sleep Apnea Feature
DEN230041 · QZW
Samsung Electronics Co., Ltd.
Anesthesiology · 251d
Not Cleared Jan 31, 2024
“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”
DEN210035 · QYV
Hologic, Inc.
Pathology · 887d
Not Cleared Jan 19, 2024
VerTouch Spinal Imaging Device
DEN220009 · QXD
Intuitap Medical, Inc.
Anesthesiology · 717d