7,246 results · 43ms · Sources: EU EUDAMED, US FDA

TECA PREMIERE

FDA 510(k)
FDA Class 2 ·Neurology

DG PORTABLE SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

TEMPUS PRO WITH ENHANCED FEATURES

FDA 510(k)
FDA Class 2 ·Cardiovascular

Tempus IC2

FDA 510(k)
FDA Class 2 ·Cardiovascular

ARCHITECT

FDA UDI
ABBOTT LABORATORIES·00380740001780·ARCHITECT iPhenobarbital Reagent Kit

ARCHITECT

FDA UDI
ABBOTT LABORATORIES·00380740001773·ARCHITECT iPhenobarbital Calibrators

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval
FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Philips HeartStart FR3 Defibrillator

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval
FDA Class 3 ·CINtec PLUS Cytology

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

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·BOSTON EQUALENS(ITAFLUOROFOCON A)/EQUALENS II(OPRIFOCON A)

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·VASCULAR SOLUTION DUETT SEALING DEVICE

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger

10 ml Z No Additive Blood Collection Tube

Basic UDI-DI
EU IVDD · Eu Ivd General ·AYSET TIBBI URUNLER VE PLASTIK TEKSTIL ELEKTRONIK GIDA TEMIZLIK MADDELERI INSAAT MUTEAHHITLIK SANAYI A.S.·1 device

9 ml Z No Additive Blood Collection Tube

Basic UDI-DI
EU IVDD · Eu Ivd General ·AYSET TIBBI URUNLER VE PLASTIK TEKSTIL ELEKTRONIK GIDA TEMIZLIK MADDELERI INSAAT MUTEAHHITLIK SANAYI A.S.·1 device

6 ml Z No Additive Blood Collection Tube

Basic UDI-DI
EU IVDD · Eu Ivd General ·AYSET TIBBI URUNLER VE PLASTIK TEKSTIL ELEKTRONIK GIDA TEMIZLIK MADDELERI INSAAT MUTEAHHITLIK SANAYI A.S.·1 device

5 ml Z No Additive Blood Collection Tube

Basic UDI-DI
EU IVDD · Eu Ivd General ·AYSET TIBBI URUNLER VE PLASTIK TEKSTIL ELEKTRONIK GIDA TEMIZLIK MADDELERI INSAAT MUTEAHHITLIK SANAYI A.S.·1 device

2 ml Z No Additive Blood Collection Tube

Basic UDI-DI
EU IVDD · Eu Ivd General ·AYSET TIBBI URUNLER VE PLASTIK TEKSTIL ELEKTRONIK GIDA TEMIZLIK MADDELERI INSAAT MUTEAHHITLIK SANAYI A.S.·1 device

4 ml Z No Additive Blood Collection Tube

Basic UDI-DI
EU IVDD · Eu Ivd General ·AYSET TIBBI URUNLER VE PLASTIK TEKSTIL ELEKTRONIK GIDA TEMIZLIK MADDELERI INSAAT MUTEAHHITLIK SANAYI A.S.·1 device

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval
FDA Class 3 ·LCS(R)TOTAL KNEE SYSTEM