VersaCross Connect LAAC Access Solution

FDA UDI

Baylis Médicale Cie Inc·00685447012627·1 x VersaCross Connect Transseptal Dilator (inc...

SavvyWire

FDA UDI

Opsens Inc·07540184030019·Pre-Shaped Pressure Guidewire

GLIDEWIRE

FDA UDI

TERUMO CORPORATION·04987350756091·RADIFOCUS GLIDEWIRE

Micro Access and Micro Introducers

FDA registration

ANGIODYNAMICS, INC.·4 products·🇺🇸 United States

Micro Access and Micro Introducers

FDA registration

AngioDynamics, Inc.·4 products·🇺🇸 United States

Isomedix Operations, Inc.

FDA registration

Isomedix Operations, Inc.·4 products·🇺🇸 United States

Micro Access Sets

FDA registration

ARGON MEDICAL DEVICES, INC.·4 products·🇺🇸 United States

K051655

FDA registration

Sterigenics U.S., LLC·4 products·🇺🇸 United States

Zurich Medical Accessory Cable

FDA registration

Zurich Medical Inc·4 products·🇺🇸 United States

Wire, Guide, Catheter

FDA classification

FDA Class 2 ·Wire, Guide, Catheter

Antiserum, Cf, Varicella-Zoster

FDA classification

FDA Class 2 ·Antiserum, Cf, Varicella-Zoster

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A

FDA Pre-Market Approval

BRAVA- BRAVA QUAD , CONCERTO II , CONSULTA , MAXIMO II, PROTECTA, PROTECTA XT,VIVA QUAD, QUAD S AND IX CRT-D'S

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF TORIC POSTERIOR CHANBER IOL, ACRYSOF TORIC SINGLE-PIECE NATURAL IOL, ACRYSOF IQ TORIC IOL & ACRYSOF TORIC IOL

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION MULTI-STRATEGY COCHLEAR IMPLANT

Wire, Guide, Catheter, Exempt

FDA classification

FDA Class 2 ·Wire, Guide, Catheter, Exempt

BE19/819943491

Certificate

MDD Annex II (excluding section 4)·IQ Messenger B.V·SGS Belgium NV·1 Basic UDI-DI

2114129CE01

Certificate

IVDD Annex IV (excluding sections 4, 6)·IQ Products BV·DEKRA Certification B.V.·1 Basic UDI-DI

2114921

Certificate

IVDD Annex IV (excluding sections 4, 6)·IQ Products BV·DEKRA Certification B.V.·1 Basic UDI-DI

AngioDynamics

FDA UDI

ANGIODYNAMICS, INC.·H787065970370·Stiffened Micro Introducer Kit