ClearanceBrief

Latest 510(k) clearances

Newest first, 50 per page. Open a clearance to see any recalls that name it.

Decided510(k)Device and applicantCode
Oct 23, 2026K263407Tempo Plating System
Pace Surgical
HRS
Oct 23, 2026K263380STAR Apollo™ Mapping System
Rhythm AI, Ltd., GB
DQK
Oct 23, 2026K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with
Smith & Nephew, Inc.
MBI
Oct 23, 2026K262779ANTHEM™ Fracture System
Globus Medical, Inc.
HRS
Oct 23, 2026K262752Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9)
Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd., CN
OHS
Oct 23, 2026K262080OTOPLAN
Cascination AG, CH
QQE
Oct 23, 2026K261982RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)
Smith & Nephew Medical, Ltd., GB
OMP
Oct 23, 2026K261792DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent
Medtronic
Oct 23, 2026K261679BlineSlide
Deep Breathe, Inc., CA
POK
Oct 23, 2026K261670Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Ty
Poly Medicure Limited, IN
LJH
Oct 23, 2026K261293EASYMAX Voice Blood Glucose Monitoring System
EPS Bio Technology Corp., TW
NBW
Oct 23, 2026K260776VENTANA MMR IHC Panel
Roche Tissue Diagnostics, Inc.
PZJ
Oct 23, 2026K260640Kinetic Software Library
Monebo Technologies, Inc.
DPS
Oct 23, 2026K260421LuxDesign
LuxCreo, Inc.
PNN
Oct 23, 2026K260302B·R·A·H·M·S MR-proADM KRYPTOR; B·R·A·H·M·S MR-proADM KRYPTOR CAL; B·R·A·H·M·S MR-proADM KRYPTOR QC
B·R·A·H·M·S GmbH (part of Thermo Fisher Scientific), DE
SJQ
Oct 23, 2026K260275Mobile Dental Solution (Model: DS50, DS70, DS90)
Guangdong JINME Medical Technology Co., Ltd., CN
EIA
Oct 23, 2026K260251BreathCare PAP III (YH-390N)
Suzhou Yuyue Medical Technology Co., Ltd., CN
BZD
Oct 23, 2026K253875OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric Biweekly Silic
Visco Vision, Inc., TW
LPL
Oct 22, 2026K263421Veritas Shoulder System
restor3d, inc.
PHX
Oct 22, 2026K263333Xpert Xpress CoV-2/Flu plus
Cepheid®
QOF
Oct 22, 2026K262701PicoPeak Picosecond Nd:Yag Laser System (Bella-9)
Beijing Sea Heart International Science and Technologyco.Ltd, CN
GEX
Oct 22, 2026K262184GANNET®
BAAT Medical Products B.V., NL
JDO
Oct 22, 2026K262126Cerclage Wires;K-wires;Steinmann Pins
MK Medical GmbH, DE
HTY
Oct 22, 2026K262084S.I.N. Instruments Kits
S.I.N. Implant System Ltda, BR
KCT
Oct 22, 2026K261565FAQ™ (FAQ 411)
Foreo, Inc.
NFO
Oct 22, 2026K261295MultiNeO Dental Implant System
Alpha Bio Tec , Ltd., IL
DZE
Oct 22, 2026K260920Accelagen Advanced Surgical Collagen Matrix, 1cc (CG-01AA); Accelagen Advanced Surgical Collagen Matrix, 2cc (CG-02AA);
Berkeley Advanced Biomaterials
KGN
Oct 22, 2026K260686Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter
Zylox Medtech Co., Ltd., CN
PNO
Oct 22, 2026K260261Gravity Blood Sets with 200µm Filter
B.Braun Medical, Inc.
FPA
Oct 22, 2026K260230Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V)
Suzhou Medical Appliance Factory, CN
BWK
Oct 21, 2026K263422Mint ACE Pump
Beta Bionics, Inc.
QFG
Oct 21, 2026K263352TeKBrace Knotless Anchor
TheraMicro
MBI
Oct 21, 2026K263319ACHM30 AtriClip FLEX-Mini LAA Exclusion System
AtriCure, Inc.
PZX
Oct 21, 2026K262980INNI-CERA (BCM-W500, BCM-W1000)
DentMedi Co., Ltd., KR
EIH
Oct 21, 2026K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody Syst
Alphatec Spine, Inc.
MAX
Oct 21, 2026K262573SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control
Maine Molecular Quality Controls, Inc.
PMN
Oct 21, 2026K262136BIOFIRE SPOTFIRE Vaginitis (VG) Panel
Biofire Diagnostics, LLC
PQA
Oct 21, 2026K262021Toro 71 Aspiration Catheter; Toro Aspiration Tubing
Toro Neurovascular, Inc.
NRY
Oct 21, 2026K261788Eden PACS
Higia., Inc. d/b/a Eden
LLZ
Oct 21, 2026K261531PV-iCurve Pro
Perception Vision Medical Technology Co., Ltd., CN
LLZ
Oct 21, 2026K261347DASH Flu A/B Test
Nuclein, LLC
OCC
Oct 21, 2026K261252Versius Surgical System (Versius Plus)
Cmr Surgical Limited, GB
SCV
Oct 21, 2026K260857Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set
Sol-Millennium Medical, Inc.
JKA
Oct 21, 2026K252736Hemotag Analysis Software (HAS)
Aventusoft, LLC
DQD
Oct 20, 2026K262937PDR Airway Device
Park Dental Research Corp.
LRK
Oct 20, 2026K262664Rongjian Self-adhesive Electrode
Bozhou Rongjian Medical Appliance Co., Ltd., CN
GXY
Oct 20, 2026K262628Picosecond Laser treatment system (Z180)
Sanhe PERFECTLASER Technology Co., Ltd., CN
GEX
Oct 20, 2026K262597Access BNP II
Beckman Coulter, Inc.
NBC
Oct 20, 2026K262421Daybreak Impression Material
Sleepcare, LLC
SHI
Oct 20, 2026K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-00
Stryker Instruments
GEI