510(k) clearances

Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2)

Fit-Pro KFT (Ltd.) - DBA E-Fit

Kentrospine Viktr-MIS® Pedicle screw system

Rivarp Medical Pvt., Ltd.

• NKB
• Class II

EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

• IYN
• Class II

EsTemp Implant

Spident Co., Ltd.

• EMA
• Class II

Arthrex Beaming System

Arthrex, Inc.

• HWC
• Class II

EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Philips Ultrasound, LLC

• IYN
• Class II

Profoject™ Safety Sliding Blood Collection Set

CMT Health PTE., Ltd.

• JKA
• Class II

Invisalign System

Align Technology, Inc.

• PNN
• Class II

3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)

Solventum US, LLC

• JOJ
• Class II

Braun Aura 9 (6042)

Cyden Limited

• OHT
• Class II

Profoject™ LOR Syringe

CMT Health PTE., Ltd.

• CAZ
• Class II

Xpert Respiratory Panel

Cepheid

• QOF
• Class II

Altis Full Face Mask

Respironics, Inc.

• BZD
• Class II

Aevice Wheeze Detection Module

Aevice Health Pte. , Ltd.

• PHZ
• Class II

syngo.CT Brain Quantification

Siemens Medical Solutions USA, Inc.

• QIH
• Class II

TumorSight Risk

SimBioSys, Inc.

• SHW
• Class II

Tempus ECG-MR

Tempus AI, Inc.

• SBQ
• Class II

easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use Cartridges

Ezisurg Medical Co., Ltd.

• GDW
• Class II

S-Patch CardioAI

Wellysis Corp.

• DQK
• Class II

UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)

Karl Storz SE & CO. KG

• HIH
• Class II

CapsoView (CVV); CapsoCloud (CLD)

CapsoVision, Inc.

• QZF
• Class II

REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)

Hyundai Bioland Co., Ltd.

• NPM
• Class II

DistaSense(TM) (v1)

Life Detection Technologies

• DRT
• Class II

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress

inomed Medizintechnik GmbH

• GWF
• Class II

OsseoFit Stemless Shoulder System

Zimmer, Inc.

• PKC
• Class II