Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx

UniCAP®

FDA UDI

ARTHROSURFACE INCORPORATED·M528U2020935A0·AKR ARTICULAR, 9.0x3.0x1.5mm

UniCAP®

FDA UDI

ARTHROSURFACE INCORPORATED·M528U2020831A0·AKR ARTICULAR, 8.0x3.0x1.0mm

UniCAP®

FDA UDI

ARTHROSURFACE INCORPORATED·M528U2020621A0·AKR ARTICULAR,6.0x2.0x1.0mm

UniCAP®

FDA UDI

ARTHROSURFACE INCORPORATED·M528U2021025A0·AKR ARTICULAR, 10.0x2.0x1.5mm

UniCAP®

FDA UDI

ARTHROSURFACE INCORPORATED·M528U2020631A0·AKR ARTICULAR, 6.0x3.0x1.0mm

UniCAP®

FDA UDI

ARTHROSURFACE INCORPORATED·M528U2020821A0·AKR ARTICULAR, 8.0x2.0x1.0mm

UniCAP®

FDA UDI

ARTHROSURFACE INCORPORATED·M528U2020721A0·AKR ARTICULAR, 7.0x2.0x1.0mm

UniCAP®

FDA UDI

ARTHROSURFACE INCORPORATED·M528U2021035A0·AKR ARTICULAR, 10.0x3.0x1.5mm

UniCAP®

FDA UDI

ARTHROSURFACE INCORPORATED·M528U2020925A0·AKR ARTICULAR, 9.0x2.0x1.5mm

UniCAP®

FDA UDI

ARTHROSURFACE INCORPORATED·M528U2020731A0·AKR ARTICULAR, 7.0x3.0x1.0mm

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROPACE RNS SYSTEM

Qor Labs

FDA UDI

LW SCIENTIFIC, INC.·00664816003442·AT Digital Centrifuge, 8-Place Rotor, Fixed Speed

C-QUR

FDA UDI

Atrium Medical Corporation·00650862315349·C-QUR MESH, 6 in. x 9 in. (15 cm x 23 cm)

Qor Labs

FDA UDI

LW SCIENTIFIC, INC.·00664816002780·10,000rpm Mini Centrifuge

Qor Labs

FDA UDI

LW SCIENTIFIC, INC.·00664816002889·Pipette pump; 10ml

C-QUR

FDA UDI

Atrium Medical Corporation·00650862315387·C-QUR MESH, 6.3 in. x 12.3 in. (16 cm x 31.2 cm)

C-QUR

FDA UDI

Atrium Medical Corporation·00650862315912·C-QUR MESH, 6.25 in. x 6.25 in. (15.5 cm x 15.5...

C-QUR

FDA UDI

Atrium Medical Corporation·00650862313260·C-QUR FX, 3 in. X 6 in. (7.5 cm x 15 cm)

C-QUR

FDA UDI

Atrium Medical Corporation·00650862315066·C-QUR MESH, 5.12 in. x 5.12 in. (13 cm x 13 cm)