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GAP ENDO-EXO MEDULLARY SYSTEM

FDA UDI
Pega Medical Inc·07540194001665·Lag Screw & Nut Ø5.5mm X 75mm / A/F 6.0mm

GAP ENDO-EXO MEDULLARY SYSTEM

FDA UDI
Pega Medical Inc·07540194000910·Nail Ø6.4mm X 200mm

GAP ENDO-EXO MEDULLARY SYSTEM

FDA UDI
Pega Medical Inc·07540194001573·Cortical Screw Ø4.0mm X 65mm

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·VNS Therapy System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Percepta Bipolar and Quadripolar CRT-P, Serena Bipolar and Quadripolar CRT-P, Solar Bipolar and Quadripolar CRT-P

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Evera MRI DF-1, MRI, S DR, S VR, XT DR, and XT VR ICD, Mirro MRI DR and MRI VR ICD, Primo MRI DR and MRI VR ICD, Protect

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Amplia MRI and MRI Quad CRT-D, Brava CRT-D and Quad CRT-D, Claria MRI and MRI Quad CRT-D, Compia MRI and MRI Quad CRT-D,

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Advisa DR, DR MRI, and SR MRI IPG, Astra S DR MRI, S SR MRI, XT DR MRI, and XT SR MRI IPG, Azure S DR MRI, S SR MRI, XT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC DF4 PROTECTA XT/PROTECTA/SECURA/MAXIMO II VR/DR ICDS

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800 Urinary Control System

FDA Pre-Market Approval
PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D ICDS

Straight Plate with Gap, 1.5/2.0 mm - 2 Holes

Device
EU MDR · Eu Md Class 2b ·GPC Medical Limited·On the market·31 countries

Lombardi Gap Balancing Feml Tib Spreader Large w/LR

Device
EU MDR · Eu Md Class 1 ·Innomed, Inc.·On the market

Lombardi Gap Balancing Feml Tib Spreader Small w/Lock

Device
EU MDR · Eu Md Class 1 ·Innomed, Inc.·On the market

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·COMFORTCARE GP(R) WETTING AND SOAKING SOLUTION

Lens, Contact (Polymethylmethacrylate)

FDA Pre-Market Approval
FDA Unclassified ·GP-II(TM) (POROFOCON B) CONTACT LENS

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·Alinity i AFP Reagent Kit

PATIENT POSITIONING INSTRUMENTS - CONSUMABLES

Device
EU MDR · Eu Md Class 1 ·Klarity Medical & Equipment(GZ) Co.,Ltd.·On the market

PATIENT POSITIONING INSTRUMENTS - CONSUMABLES

Device
EU MDR · Eu Md Class 1 ·Klarity Medical & Equipment(GZ) Co.,Ltd.·On the market

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·Alinity i Free PSA Reagent Kit