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.

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

Filters: Cleared only ×
175,230 results
8929–8952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 2023
Titan Dental Design
K232429 · PNN
Clearadvance, LLC
Dental · 63d
Cleared Oct 13, 2023
VyLink™ Spinal Screw System
K231744 · NKB
Vy Spine, LLC
Orthopedic · 121d
Cleared Oct 13, 2023
S1
K231672 · NPM
Medpark Co., Ltd.
Dental · 127d
Cleared Oct 13, 2023
Veuron-Brain-pAb3
K231642 · LLZ
Heuron Co., Ltd.
Radiology · 130d
Cleared Oct 13, 2023
The Evolve System with the Transform Applicator
K231495 · GEI
Inmode , Ltd.
General & Plastic Surgery · 143d
Cleared Oct 13, 2023
Macro & Micro-Test HCG Pregnancy Test Midstream
K230741 · LCX
Jiangsu Macro & Micro-Test Med-Tech...
Chemistry · 210d
Cleared Oct 13, 2023
Serena Sleep Night Guard
K230495 · MQC
Meris Investment Group
Dental · 232d
Cleared Oct 13, 2023
Xpert® Xpress CoV-2 plus
K230440 · QQX
Cepheid
Microbiology · 234d
Cleared Oct 13, 2023
SpotLight/SpotLight Duo (with DLIR option)
K230370 · JAK
Arineta , Ltd.
Radiology · 245d
Cleared Oct 13, 2023
Neuroblade System
K230125 · GWG
Clearmind Biomedical
Neurology · 269d
Cleared Oct 13, 2023
BONHAWA Respiratory Humidifier
K223863 · BTT
Telesair, Inc.
Anesthesiology · 294d
Cleared Oct 13, 2023
MRI compatibility for existing BioHorizons dental implants and abutments
K223697 · DZE
BioHorizons Implant Systems, Inc.
Dental · 308d
Cleared Oct 13, 2023
APIS (R), VERIS (TM)
K222143 · FRO
Sweetbio, Inc.
General & Plastic Surgery · 450d
Cleared Oct 13, 2023
Motiva Flora SmoothSilk Tissue Expander
K211676 · LCJ
Motiva USA, LLC
General & Plastic Surgery · 864d
Cleared Oct 12, 2023
Montage- XT Settable, Resorbable Hemostatic Bone Putty
K232998 · MTJ
Orthocon, Inc.
Orthopedic · 20d
Cleared Oct 12, 2023
Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
K232852 · DXF
Cross Vascular, Inc.
Cardiovascular · 28d
Cleared Oct 12, 2023
Monkey RingsTM External Fixation System
K232838 · KTT
Paragon 28, Inc.
Orthopedic · 28d
Cleared Oct 12, 2023
Cross Vascular RF Generator and Footswitch (optional accessory)
K232809 · GEI
Cross Vascular, Inc.
General & Plastic Surgery · 30d
Cleared Oct 12, 2023
TMINI™ Miniature Robotic System
K232802 · OLO
THINK Surgical, Inc.
Orthopedic · 30d
Cleared Oct 12, 2023
FREEPRINT® splintmaster
K232448 · MQC
Detax GmbH
Dental · 59d
Cleared Oct 12, 2023
ValvuloPro Valvuloplasty Balloon Catheter
K231814 · OZT
Dongguan TT Medical, Inc.
Cardiovascular · 113d
Cleared Oct 12, 2023
Axoguard HA+ Nerve Protector (AGHA12)
K231708 · JXI
Axogen Corporation
Neurology · 122d
Cleared Oct 12, 2023
Scenaria View 4.2
K231574 · JAK
Fujifilm Healthcare Americas Corporation
Radiology · 134d
Cleared Oct 12, 2023
Stethophone
K231551 · DQD
Sparrow Acoustics, Inc.
Cardiovascular · 135d