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Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval
FDA Class 2 ·DORNIER LITHOTRIPTER MODELS HM3 AND HM4

CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

TruDi™ Navigation System

FDA UDI
BIOSENSE WEBSTER (ISRAEL) LTD.·10846835018639·TruDi™ Navigation System

ILLUMISITE

FDA UDI
Covidien LP·10884521779983·Procedure Software V1.0

NextAR TKA Platform

FDA UDI
Medacta International SA·07630971281318·NextAR curved stylus

Endoscope tracker EM

FDA UDI
Scopis GmbH·B057U1037020·The Endoscope tracker EM provides a way to trac...

NextAR Spine Platform

FDA UDI
Medacta International SA·07630345709981·Sterile NextAR Spine Solid Drill Ø2,4mm depth 50mm

HOLO

FDA UDI
Surgalign Spine Technologies, Inc.·00850028694237·HOLO AR Glasses

Tracking Bracket

FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436106221·Reusable non-sterile tracking bracket for use w...

NextAR Spine Platform

FDA UDI
Medacta International SA·07630345709868·NextAR Spine Solid Drill Ø3,6mm depth 25mm

PKS Patient Reference DRF

FDA UDI
PATHKEEPER SURGICAL LTD·07290019120193·

SCOUT®

FDA UDI
MERIT MEDICAL SYSTEMS, INC.·00884450582718·

NextAR RSA Platform

FDA UDI
Medacta International SA·07630345731197·NextAR drill guide for peripheral screws - right

eTRAX™ Needle System Starter Kit

FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436111058·Reusable non-sterile needle sensor with sterile...

NextAR TKA Platform

FDA UDI
Medacta International SA·07630971288751·NextAR tracker holder left large

Joimax® Intracs® EM Patient Mapper - LAT

FDA UDI
Joimax GmbH·04250337118220·

NextAR Spine Platform

FDA UDI
Medacta International SA·07630345709684·NextAR Spine Solid Drill Ø2,4mm depth 40mm

Tracking Bracket

FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436114271·Reusable non-sterile tracking bracket for use w...

eTRAX™ Needle

FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436103555·Sterile needle, 18GA x 17.7cm with (7.6 tapered...

Cirq Robotic Tracking Array Spine 10.0

FDA UDI
Brainlab AG·04056481141240·