Plus

FDA registration

ICU Medical Healthcare Manufacturing S.A. de C.V.·1 product·🇲🇽 Mexico

MASK, GAS, ANESTHETIC

FDA registration

NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD.·1 product·🇨🇳 China

DELBIO GS2 Nucleic Acid Extraction Kit

Device

EU IVDR · Eu Ivd Class A ·DELBIO INC.·On the market

DELBIO GS1 Nucleic Acid Extraction Kit

Device

EU IVDR · Eu Ivd Class A ·DELBIO INC.·On the market·32 countries

DELBIO GS2 Nucleic Acid Extraction Kit

Device

EU IVDR · Eu Ivd Class A ·DELBIO INC.·On the market·32 countries

MICROAIR PUP

FDA 510(k)

FDA Class 2 ·Physical Medicine

FLUIDIZED AIR BED

FDA 510(k)

FDA Class 2 ·Physical Medicine

MICROAIR TURN-Q

FDA 510(k)

FDA Class 2 ·Physical Medicine

MICROAIR FLUIDIZED AIR BED

FDA 510(k)

FDA Class 2 ·Physical Medicine

MICROAIR 3500

FDA 510(k)

FDA Class 2 ·Physical Medicine

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G System with SmartGuard, MiniMed 630G System with GS3, GS3 Transfer to MPROC

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE G/SG LEADS

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE CARDIOFORM Septal Occluder (GSO)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE S /GS /G

Stille GS2

FDA UDI

Stille AB·07332339232580·TABLE, OPERATINGROOM, ELECTRICAL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS AND G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J

FDA 510(k)

FDA Class 2 ·Cardiovascular

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE G/SG WITH 4-SITE CONNECTOR DEFIBRILLATION LEADS, ENDOTAK RELIANCE G/SG DEFIBRILLATION LEADS

ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE

FDA 510(k)

FDA Class 1 ·General Hospital