Search FDA 510(k) Devices

5,418 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2023–2023 ×
3,347 results
937–960 of 3,347
Cleared Sep 27, 2023
Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer
K214117 · LCP
Abbott Diagnostics Technologies AS
Chemistry · 636d
Cleared Sep 26, 2023
ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic...
K232617 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Sep 26, 2023
ES Series V2
K232336 · IYN
E-Scopics
Radiology · 53d
Cleared Sep 26, 2023
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
K232233 · NXC
Align Technology, Inc.
Dental · 61d
Cleared Sep 26, 2023
DEKA PHYSIQ 360
K231971 · PKT
El.En S.P.A.
General & Plastic Surgery · 85d
Cleared Sep 26, 2023
AVVIGO'+ Multi-Modality Guidance System
K230884 · DQK
Boston Scientific Corporation
Cardiovascular · 180d
Cleared Sep 26, 2023
Arthrex Univers Apex OptiFit Humeral Stem
K230513 · KWS
Arthrex, Inc.
Orthopedic · 214d
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
Not Cleared Sep 26, 2023
VasQ
DEN220026 · QVQ
Laminate Medical Technologies , Ltd.
Cardiovascular · 515d
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