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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
8665–8688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 12, 2023
Stable-L Standalone Lumbar Interbody System
K231486 · OVD
Nexus Spine, LLC
Orthopedic · 142d
Cleared Oct 12, 2023
MONTAGE-QS Settable, Resorbable Bone Putty
K231475 · GXP
Orthocon, Inc.
Neurology · 143d
Cleared Oct 12, 2023
MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic...
K231231 · HWC
Paragon 28, Inc.
Orthopedic · 167d
Cleared Oct 12, 2023
Collagen Wound Dressing
K231152 · KGN
Winner Medical Co., Ltd.
General & Plastic Surgery · 171d
Cleared Oct 12, 2023
Exactech® Vantage® Total Ankle System
K230717 · HSN
Exactech, Inc.
Orthopedic · 211d
Cleared Oct 12, 2023
Skypro, Surgical Gown 6021
K230707 · FYA
Skypro Medical Supplies Company
General Hospital · 212d
Cleared Oct 12, 2023
Monopolar Electrode Surgical Instrument
K230650 · GEI
Vhmed (Nantong) Co. , Ltd.
General & Plastic Surgery · 217d
Cleared Oct 12, 2023
Artemis, Artemis TPO, Artemis MX
K222222 · QTZ
Eigen
Radiology · 444d
Cleared Oct 11, 2023
EMPHASYS Femoral Stems
K233233 · LZO
Depuy Ireland UC
Orthopedic · 13d
Cleared Oct 11, 2023
Synq Software Version 1.3
K232981 · LNH
Synaptive Medical, Inc.
Radiology · 20d
Cleared Oct 11, 2023
VASSALLO GT 018 G12
K232578 · DQX
Filmec Co. , Ltd.
Cardiovascular · 47d