Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval

FDA Class 3 ·KARL STORZ Photodynamic Diagnostic D-Light C System

FDA Pre-Market Approval

BRAVA CRT-D, CONCERTA II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA/PROTECTA XT CRT-D S/VIVA XT CRT-D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERA, SENSIA IPG'S; ADVISA DR/DR MRI IPG'S

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR/VR, EVERA XT DR/VR ICD'S; MAXIMO II ICD; PRTOECTA/PROTECTA XT ICD'S; SECURA ICD, VIRTUOSO II DR/VR ICD

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN Left Atrial Appendage Closure Device and Delivery System

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH

Nordlys

FDA UDI

Candela Corporation·00817495023434·Multi-modality skin surface treatment system: I...

Ellipse

FDA UDI

Ellipse A/S·05713530000178·Multi-modality skin surface treatment system: I...

Ellipse

FDA UDI

Ellipse A/S·05713530000420·Multi-modality skin surface treatment system: I...

ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NOOANCE LED AND LASER HELMET(Model: M-120, M-282 PRO)

FDA registration

Shenzhen Kaiyan Medical Equipment Co., Ltd·1 product·🇨🇳 China

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Astron Pulsar/Pulsar-18 Stent System

α-Amylase Kit (IFCC Method)

Device

EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·On the market·2 countries

α-Amylase Kit (IFCC Method)

Device

EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·On the market·2 countries

α-Amylase Kit (IFCC Method)

Device

EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·On the market·2 countries

ENZYMES LINEARITY VERIFIER (For Roche Systems) (ENZYMES LIN VER ROCHE)

FDA UDI

RANDOX LABORATORIES LIMITED·05055273216486·Enzymes Linearity Verifiers are an in vitro dia...

OPTICS ONE

FDA UDI

MEDICAL TECHNIQUE, INC.·00815384021639·Leica/Wild Microscope Drape 42 x 120 Glass Lens

OPTICS ONE

FDA UDI

MEDICAL TECHNIQUE, INC.·00815384023008·Ultrasound Probe Drape w/gel 6 X 96