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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Not cleared only ×
483 results
73–96 of 483
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
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
Not Cleared Jan 12, 2024
Fibresolve
DEN220040 · QWO
Imvaria, Inc.
Radiology · 562d
Not Cleared Jan 12, 2024
DermaSensor
DEN230008 · QZS
Dermasensor, Inc.
General & Plastic Surgery · 344d
Not Cleared Jan 12, 2024
Osteoboost Belt
DEN230015 · QZO
Bone Health Technologies, Inc.
Orthopedic · 329d
Not Cleared Jan 11, 2024
BrainSee
DEN220066 · QWT
Darmiyan, Inc.
Neurology · 469d
Not Cleared Dec 22, 2023
BioTraceIO Lite
DEN230020 · QZL
Techsomed Medical Technologies , Ltd.
Radiology · 267d
Not Cleared Dec 15, 2023
Body Temperature Software (BTS)
DEN230050 · QZA
Fitbit, LLC
General Hospital · 151d
Not Cleared Dec 12, 2023
NaviCam ProScan
DEN230027 · QZF
Ankon Technologies Co., Ltd.
Gastroenterology & Urology · 242d