10,000 results · 116ms · Sources: EU EUDAMED, US FDA

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Sharps Needle Destruction Device

FDA Pre-Market Approval
FDA Class 2 ·NEEDLE ZAP

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VOYAGER RX CORONARY DILATATION CATHETER

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval
FDA Class 3 ·BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE SENSE BIPOLAR LEAD

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval
FDA Class 3 ·BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·BIOLON (1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)

Bone Sonometer

FDA Pre-Market Approval
FDA Class 2 ·SUNLIGHT OMNISENSE ULTRASOUND BONE SONOMETER

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM, TOTABLATOR LASER WELDING PROCESS

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT

3909,8,4,VOL,TV,N(NORM.CL),LT,(2)RD LED

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828148696·3909,8,4,VOL,TV,N(NORM.CL),LT,(2)RD LED

HANDHELD PENDANT,800,8,N,LT 1 & 2,JW

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828128544·HANDHELD PENDANT,800,8,N,LT 1 & 2,JW

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF INTRAOCULAR LENSES (IOLS)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT AUSAB

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·BARD TEGRESS URETHRAL IMPLANT

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·PMMA ANTERIOR CHAMBER IOLS

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF RESTOR APODIZED DIFFRACTIVE IOLS

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF IQ RESTOR +3.0D ADD POWER POSTERIOR CHAMBER IOLS

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·EPIC VASCULAR SELF-EXPANDING STENT SYSTEM