8 results · 6ms · 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.

ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099

FDA Enforcement
Class II ·Terminated·Orthofix Srl·November 20, 2019

ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918

FDA Enforcement
Class II ·Terminated·Orthofix Srl·November 20, 2019

ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242510901

FDA Enforcement
Class II ·Terminated·Orthofix Srl·November 20, 2019

ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075

FDA Enforcement
Class II ·Terminated·Orthofix Srl·November 20, 2019

ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856068

FDA Enforcement
Class II ·Terminated·Orthofix Srl·November 20, 2019

ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603

FDA Enforcement
Class II ·Terminated·Orthofix Srl·November 20, 2019

1ml of DTT in liquid phase, in PET tube with capture cap, in bulk

FDA Enforcement
Class II ·Ongoing·Copan Italia·December 24, 2025

1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System

FDA Enforcement
Class II ·Ongoing·Copan Italia·December 24, 2025