420 results · 23ms · Sources: EU EUDAMED, US FDA

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·RAPIDSCREEN RS-2000D

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT HAVAB -M EIA

Enzyme Immunoassay, Cannabinoids

FDA Pre-Market Approval
FDA Class 2 ·DR. BROWN'S HOME DRUG TESTING KIT

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·AMPLICOR HCV TEST,VERSION 2.0

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·HAVAB (R) EIA

Wheelchair, Stair Climbing

FDA Pre-Market Approval
FDA Class 2 ·INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval
FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD

Bone Sonometer

FDA Pre-Market Approval
FDA Class 2 ·MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval
FDA Class 2 ·BELOS VR-T ICD

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval
FDA Class 2 ·KAINOX RV-S/ KAINOX VCS ICD LEADS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·SCIMED PTCA CATHETERS

System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval
FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval
FDA Class 2 ·BELOS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

Bone Sonometer

FDA Pre-Market Approval
FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

FDA classification
FDA Class 2 ·Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval
FDA Class 2 ·BEDSIDE(TM) SINGLE CHAMBER, TXTERNAL PULSE GENERATOR, MODEL 4170

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·ORACLE MEGASONICS FIVE-64 PTCA CATHETER

Bone Sonometer

FDA Pre-Market Approval
FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER