132 results · 21ms · Sources: EU EUDAMED, US FDA

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

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

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval
FDA Class 3 ·ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM

Gastric Emptying Breath Test

FDA Pre-Market Approval
FDA Class 3 ·13C-Spirulina Gastric Emptying Breath Test (GEBT)

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval
FDA Class 3 ·BIOTRIN INTERNATIONALS PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval
FDA Class 3 ·BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE

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

FDA Pre-Market Approval
FDA Class 3 ·DIASORIN ETI-CORE-IGMK PLUS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENDOTAK RELIANCE/S/ENDOTAK ENDURANCE EZ/ENDOTAK RELIANCE SG/G

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA Pre-Market Approval
FDA Class 3 ·T-SPOT. TB TEST

Gastric Emptying Breath Test

FDA Pre-Market Approval
FDA Class 3 ·13C-SPIRULINA GEBT/13C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APILGRAF(GRAFTSKIN)

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

FDA Pre-Market Approval
FDA Class 3 ·AXSYM CORE 2.0

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

FDA Pre-Market Approval
FDA Class 3 ·AXSYM CORE-M 2.0

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·RITHRON-XR CORONARY STENT SYSTEM

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·AV PLUS DX, MODEL 1368

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·AFFINITY,IDENTITY,INTEGRITY & ENTITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03