2,217 results
·
38ms
·
Sources: EU EUDAMED, US FDA
ML-10 (Electric Patient Lift)
FDA registration
MAN & TEL COMPANY LIMITED·1 product·🇰🇷 South Korea
Genisis All Suture Anchor (JS type)
FDA registration
STERICO Co., Ltd.·1 product·🇰🇷 South Korea
Boncare Disposable Underpads
FDA registration
J2LFA CO., LTD.·1 product·🇰🇷 South Korea
Osseofuse Dental Implant System
FDA registration
GREENPIA TECHNOLOGY INC.·2 products·🇰🇷 South Korea
AEGIS & AEGIS II SPINAL SYSTEM
FDA registration
GREENPIA TECHNOLOGY INC.·3 products·🇰🇷 South Korea
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR IMMUNOASSAY
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·COGNIS, PROGENY CRT-D AND NG CRT-D MODELS
EIA NEGATIVE CALIBRATOR
FDA UDI
UTAK LABORATORIES, INC.·B800EIANEGUFRX0·EIA NEGATIVE CALIBRATOR
DAU NEGATIVE
FDA UDI
UTAK LABORATORIES, INC.·B800DAUNEGV2FCH0·DAU NEGATIVE
DRUGS OF ABUSE NEGATIVE
FDA UDI
UTAK LABORATORIES, INC.·B800DANEGBMFMMB0·DRUGS OF ABUSE NEGATIVE
DRUGS OF ABUSE NEGATIVE SCREEN
FDA UDI
UTAK LABORATORIES, INC.·B800DAUNEGUFPHHC0·DRUGS OF ABUSE NEGATIVE SCREEN
DRUGS OF ABUSE SCREEN NEGATIVE
FDA UDI
UTAK LABORATORIES, INC.·B800DAUNEGFQCVU0·DRUGS OF ABUSE SCREEN NEGATIVE
MicroScan MSF Neg/Pos ID Panel Type 2
Device
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Inc.·On the market·14 countries
MicroScan Neg Non Entero Combo Panel Type 71
Device
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Inc.·On the market·14 countries
MicroScan MSF Neg/Pos ID Panel Type 2
Device
EU IVDD
·
Eu Ivd General
·Beckman Coulter Inc.·On the market·32 countries
MicroScan Neg Non Entero Combo Panel Type 71
Device
EU IVDD
·
Eu Ivd General
·Beckman Coulter Inc.·On the market·32 countries
MULTIPLE SPECTACLE LENS
FDA 510(k)
FDA Class 1
·Ophthalmic
BLENDED BIFOCAL
FDA 510(k)
FDA Class 1
·Ophthalmic
0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX
FDA 510(k)
FDA Class 1
·Ophthalmic
POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)
FDA 510(k)
FDA Class 1
·Ophthalmic