86 results · 27ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Qualitative And Quantitative Hepatitis B Virus Antibody Assays

FDA Pre-Market Approval
FDA Class 2 ·MONOLISA ANTI-HBS EIA

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·BIO-RAD MONOLISA ANTI-HBS EIA

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·BIO-RAD MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·MONOLISA ANTI-HBS EIA

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·BIO-RAD MONOLISA ANTI-HBS EIA & ANTI-HBS CALIBRATOR KIT

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·BIO-RAD MONOLISA ANTI-HBS EIA

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·BIO-RAD MONOLISA ANTI -HBS EIA

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·BIO-RAD MONOLISA ANTI-HBS EIA

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·BIO-RAD MONOLISA ANTI-HBS EIA

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756002233·ARM SLING

PECA®

FDA UDI
NOVASTEP·03700879510569·Bunion implant Ø4 lg48

Altus Spine Pedicle Screw System

FDA UDI
Altus Spine, LLC·00843210132020·Rod Rocker

Copper Ni-Ti - Archwire

FDA UDI
ORMCO CORPORATION·00889989025521·COPPER NITI 27 BAF 18 DIA U/S PK10

P150048

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·September 23, 2024

P150048

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·September 26, 2025

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710420500480·Anterior Lateral Wedge Osteotomy Guide, 50mm x ...

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710410500480·Anterior Closing Wedge Osteotomy Guide, 50mm x ...

HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·DORNIER EPOS ULTRA