Search FDA 510(k) Database

6,426 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
7921–7944 of 174,061
Cleared Sep 28, 2023
PIVO™ Pro Needle-free Blood Collection Device
K230865 · JKA
Becton Dickinson Infusion Therapy...
General Hospital · 183d
Cleared Sep 27, 2023
Cove Strip, OsteoCove Strip
K232668 · MQV
SeaSpine Orthopedics Corporation
Orthopedic · 26d
Cleared Sep 27, 2023
Volta AF-Xplorer
K232616 · DQK
Volta Medical
Cardiovascular · 30d
Cleared Sep 27, 2023
Micro Ace™ Advanced Micro Access System
K232609 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Sep 27, 2023
EndoGI S-Path Biliary Stent System
K232596 · FGE
Endogi Medical, Ltd.
Gastroenterology & Urology · 33d
Cleared Sep 27, 2023
Invictus® Spinal Fixation System
K232275 · NKB
Alphatec Spine, Inc.
Orthopedic · 58d
Cleared Sep 27, 2023
Thinline Sheath Introducer
K232260 · DYB
Inneuroco, Inc.
Cardiovascular · 58d
Cleared Sep 27, 2023
EZSensor XHD
K232255 · MUH
Qpix Solutions, Inc.
Radiology · 61d
Cleared Sep 27, 2023
VySpan™ PCT System
K232167 · NKG
Vy Spine, LLC
Orthopedic · 68d
Cleared Sep 27, 2023
FreedomFlow Orbital Circumferential Atherectomy System
K231538 · MCW
Cardio Flow Inc.,
Cardiovascular · 120d
Cleared Sep 27, 2023
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003,...
K231363 · NGT
Hantech Medical Device Co., Ltd.
General Hospital · 139d
Cleared Sep 27, 2023
Talon Transseptal Sheath
K231108 · DYB
Inari Medical, Inc.
Cardiovascular · 161d
Cleared Sep 27, 2023
VariLift®-C Interbody Fusion System
K231076 · ODP
Wenzel Spine, Inc.
Orthopedic · 166d
Cleared Sep 27, 2023
CEDIA Heroin Metabolite (6-AM) Assay
K231007 · DJG
Microgenics Corporation
Chemistry · 173d
Cleared Sep 27, 2023
Disposable Injection Needle AF series
K230925 · FBK
Alton (Shanghai) Medical Instruments...
Gastroenterology & Urology · 177d
Cleared Sep 27, 2023
EVOLUTION® Hinge Knee System
K230563 · KRO
Microport Orthopedics, Inc.
Orthopedic · 210d
Cleared Sep 27, 2023
Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
K222638 · NJR
Cepheid
Microbiology · 391d
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