1,560 results · 46ms · Sources: EU EUDAMED, US FDA

OP-CON SURGICAL INSTRUMENT #9

FDA 510(k)
FDA Class 1 ·Anesthesiology

CHROMIUM PLUS LEVEL 1

FDA UDI
UTAK LABORATORIES, INC.·B800CHROM1WBQD0·CHROMIUM PLUS LEVEL 1

IMMUNOSUPPRESSANTS LEVEL 1

FDA UDI
UTAK LABORATORIES, INC.·B800IMMU1WBKPNH0·IMMUNOSUPPRESSANTS LEVEL 1

OPIATES PLUS LEVEL 1

FDA UDI
UTAK LABORATORIES, INC.·B800OPIA1WBSC0·OPIATES PLUS LEVEL 1

HYDROXYCHLOROQUINE LEVEL 1

FDA UDI
UTAK LABORATORIES, INC.·B800HYDCHLOR1WBEBS0·HYDROXYCHLOROQUINE LEVEL 1

METALS LEVEL 1

FDA UDI
UTAK LABORATORIES, INC.·B800MET1WBQD0·METALS LEVEL 1

DIHYDROCODEINE LEVEL 1

FDA UDI
UTAK LABORATORIES, INC.·B800DHC1WBUK0·DIHYDROCODEINE LEVEL 1

METALS LEVEL 1

FDA UDI
UTAK LABORATORIES, INC.·B800MET1WBMAYO0·METALS LEVEL 1

DRUGS OF ABUSE 1

FDA UDI
UTAK LABORATORIES, INC.·B800DA1WBVTS0·DRUGS OF ABUSE 1

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEMS

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT Admiral DCB Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

DAB Chromogen kit, for 1250 tests

Device
EU IVDR · Eu Ivd Class A ·BioGnost Ltd.·On the market·32 countries

DAB Chromogen kit, for 250 tests

Device
EU IVDR · Eu Ivd Class A ·BioGnost Ltd.·On the market·32 countries

Titan HRP DAB 30 mL Kit

Device
EU IVDR · Eu Ivd Class A ·Lumatas BioSystems Inc·On the market·32 countries

005 PolyQ Stain DAB Substrate Buffer

Device
EU IVDR · Eu Ivd Class A ·biocyc Biotechnologie GmbH & Co. KG·On the market

BWB Ring Upside kit 10 pcs

Device
EU MDR · Eu Md Class 2b ·BIOTEC S.R.L.·On the market·19 countries

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Motion Trainer

FDA UDI
Trainer Rx, Inc. D/B/A Recoveryone·00196852042524·