Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·HEPARIN-INDUCED EXTRACORPOREAL LDL PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM

CAROLINA LIQUID CHEMISTRIES CORP.™ AMY AMYLASE REAGENT CC227

FDA UDI

CAROLINA LIQUID CHEMISTRIES CORPORATION·00817302020304·AMY (Amylase) 2 x 200 tests

MEDIU DE TRANSPORT AMIES

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·SC MEDICAMED MARKET SRL·1 device

MEDIU DE TRANSPORT AMIES

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·SC MEDICAMED MARKET SRL·1 device

Disposable Amies Sampling Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Guangxi Huadu Medical Equipment Co.,Ltd.·1 device

SPOTCHEM II Amy-wide

Basic UDI-DI

EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·1 device

AMIS*PACS FlexServer G2

Basic UDI-DI

EU MDD · Eu Md Class 2b ·ICZ.HEA a.s.·1 device

DAYLITE XENON LIGHT SOURCES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CANNULATED SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

STENTUBE LACRIMAL INTUBATION SET

FDA 510(k)

FDA Unclassified ·Unknown

CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY)

FDA 510(k)

FDA Class 1 ·Radiology

Q2 Low Pressure Power Injection Extension Set

FDA 510(k)

FDA Class 2 ·General Hospital

XSTAT-12, 3-Pack, XSTAT-12, 1-Pack

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

3M TEMPORARY CROWN & BRIDGE MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

APEX SPINE SYSTEM W/ COCR RODS

FDA 510(k)

FDA Class 2 ·Orthopedic

PLASTIC PROTECTION HEALING CAPS

FDA 510(k)

FDA Class 2 ·Dental

RADIONICS SLUIJTER-MEHTA CANNULA

FDA 510(k)

FDA Class 2 ·Neurology

ASTRA-OCT Spine System

FDA 510(k)

FDA Class 2 ·Orthopedic

Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets

FDA 510(k)

FDA Class 2 ·General Hospital