Search FDA 510(k) Database

6,427 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
7945–7968 of 174,061
Cleared Sep 26, 2023
MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
K230398 · JEY
Medcad
Dental · 222d
Cleared Sep 26, 2023
OFIX MIS App
K230252 · LLZ
Orthofix US, LLC
Radiology · 239d
Cleared Sep 26, 2023
Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC,...
K223496 · NHA
Prismatik Dentalcraft, Inc.
Dental · 309d
Cleared Sep 26, 2023
EasyStat 300
K220396 · CEM
Medica Corporation
Chemistry · 592d
Cleared Sep 26, 2023
Access Thyroglobulin Antibody II
K213517 · JZO
Beckman Coulter, Inc.
Immunology · 692d
Cleared Sep 25, 2023
IdentiTi ALIF Interbody Systems
K232097 · OVD
Alphatec Spine, Inc.
Orthopedic · 74d
Cleared Sep 25, 2023
PEACH 2, PEACH 2 Duo, PEACH 2 go
K231977 · OHT
Foreo, Inc.
General & Plastic Surgery · 84d
Cleared Sep 25, 2023
EFAI RTSUITE CT HCAP-Segmentation System
K231928 · QKB
Ever Fortune.Ai, Co., Ltd.
Radiology · 87d
Cleared Sep 25, 2023
Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
K231891 · OTM
Coloplast
Gastroenterology & Urology · 90d
Cleared Sep 25, 2023
BD Texium™ Needle-Free Syringe
K231888 · FMF
Care Fusion
General Hospital · 90d
Cleared Sep 25, 2023
Cervical Spine Truss System (CSTS)
K231739 · OVE
4Web Medical, Inc.
Orthopedic · 103d
Cleared Sep 25, 2023
TiLink-P SI Joint Fusion System
K230857 · OUR
SurGenTec, LLC
Orthopedic · 180d
Cleared Sep 25, 2023
Smileyscope System (Therapy Mode)
K230825 · QRA
Smileyscope Holding, Inc.
Physical Medicine · 185d
Cleared Sep 25, 2023
EndoCore
K230778 · KTI
Praxis Medical, LLC
Anesthesiology · 188d
Cleared Sep 25, 2023
Holter ECG and ABP System
K230184 · DSH
Edan Instruments, Inc.
Cardiovascular · 245d
Cleared Sep 25, 2023
Exactech Equinoxe PHx Fracture System
K223933 · HRS
Exactech, Inc.
Orthopedic · 269d
Cleared Sep 25, 2023
Self-Fitting hearing aids
K221052 · QUH
Huizhou Jinghao Medical Technology...
Ear, Nose, Throat · 532d
Cleared Sep 24, 2023
ADVIA Centaur® NT-proBNPII (PBNPII)
K220265 · NBC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 601d
Cleared Sep 23, 2023
B.Light Clear Evo and B.Light Restore Evo
K223919 · OHS
Bemer Int AG
General & Plastic Surgery · 268d
Cleared Sep 23, 2023
Osstem Implant System
K222778 · DZE
Osstem Implant Co., Ltd.
Dental · 374d
Cleared Sep 22, 2023
DX. Bond V Dental Bonding Adhesive
K232978 · KLE
Sino-Dentex Co., Ltd.
Dental · 1d
Cleared Sep 22, 2023
CATHTONG™ II PICC Catheter
K232594 · LJS
L&Z Us, Inc.
General Hospital · 28d
Cleared Sep 22, 2023
CATHTONG™ II PICC Catheter
K232571 · LJS
L&Z Us, Inc.
General Hospital · 29d
Cleared Sep 22, 2023
UroLift 2 ATC Advanced Tissue Control System
K232558 · PEW
Neotract, Inc.
Gastroenterology & Urology · 30d