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