887 results · 38ms · Sources: EU EUDAMED, US FDA

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·PHYLAX AV ICD SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·KRONOS LV-T CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PHYLAX IMPLANTABLE CARDIOVERTER DIFIBRILLATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC

LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Human Growth Hormone (hGH) Assay Reagent Kit (CMIA)

Device
EU IVDD · Eu Ivd General ·Hangzhou Realy Tech Co.,Ltd.·On the market

Human Growth Hormone (hGH) Assay Reagent Kit (CMIA)

Device
EU IVDD · Eu Ivd General ·Hangzhou Cybereagen Biotech Co., Ltd.·On the market

IGH/MAF Plus v2 Translocation, Dual Fusion Probe

Device
EU IVDR · Eu Ivd Class C ·Cytocell Limited·On the market·32 countries

IGH/MAF Plus v2 Translocation, Dual Fusion Probe

Device
EU IVDR · Eu Ivd Class C ·Cytocell Limited·On the market·32 countries

BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ANTI-GM & ANTI-KM TYPING SERUMS

FDA 510(k)
FDA Class 2 ·Immunology

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·PHILOS PULSE GENERATORS AND ASSOCIATED PROGRAMMER SOFTWARE.

Monobind AccuBind hGH ELISA Kit - 192 Wells

FDA UDI
MONOBIND, INC.·00816870021072·

Monobind AccuBind hGH ELISA Kit - 96 Wells

FDA UDI
MONOBIND, INC.·00816870021065·

Monobind AccuLite hGH CLIA Kit - 192 Wells

FDA UDI
MONOBIND, INC.·00816870022710·

Monobind AccuLite hGH CLIA Kit - 96 Wells

FDA UDI
MONOBIND, INC.·00816870022703·

Formfit Back Support

FDA registration
OSSUR EUROPE B.V.·1 product·🇳🇱 Netherlands

i-Limb Wrist

FDA registration
OSSUR EUROPE B.V.·1 product·🇳🇱 Netherlands

Universal Abdominal Binder

FDA registration
OSSUR EUROPE B.V.·1 product·🇳🇱 Netherlands

Icelock® 772 Male Pyramid TI

FDA registration
OSSUR EUROPE B.V.·1 product·🇳🇱 Netherlands