Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas® KRAS Mutation Test

FDA Pre-Market Approval

cobas® HPV

CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Orfit Industries

FDA UDI

Orfit Industries NV·05420028763223·Thermoplastic Mask Nose (10 PCS) P10106-301 10...

Orfit Industries

FDA UDI

Orfit Industries NV·05420028764176·3pt Head Mask - Nose Hole - Neck Flap Extra Cra...

Orfit Industries

FDA UDI

Orfit Industries NV·05420028700846·3pt Paediatric Mask for HP PRO Solution - Mediu...

Orfit Industries

FDA UDI

Orfit Industries NV·05420028715338·3pt Paediatric Mask for HP PRO Solution - Small...

Orfit Industries

FDA UDI

Orfit Industries NV·05420028734124·3pt Hybrid Head Open Face Mask for BiteFix Eff ...

Map-iT

FDA UDI

ACCESS POINT TECHNOLOGIES, INC.·00818087020350·Steerable Quadripolar Catheter, Multi-Purpose D...

Map-iT

FDA UDI

ACCESS POINT TECHNOLOGIES, INC.·00818087020381·Fixed Curve Decapolar Catheter with Guidewire Tip

Map-iT

FDA UDI

ACCESS POINT TECHNOLOGIES, INC.·00818087020008·Fixed Curve Decapolar Catheter, Multi-Purpose A...

Map-iT

FDA UDI

ACCESS POINT TECHNOLOGIES, INC.·00818087020183·Fixed Curve Duo-Decapolar Catheter with Guidewi...

Map-iT

FDA UDI

ACCESS POINT TECHNOLOGIES, INC.·00818087020152·Fixed Curve Decapolar Catheter with Guidewire Tip

Map-iT

FDA UDI

ACCESS POINT TECHNOLOGIES, INC.·00818087020374·Shrouded Quad Extension Cable, Steerable 4 pole...

Map-iT

FDA UDI

ACCESS POINT TECHNOLOGIES, INC.·00818087020169·Fixed Curve Decapolar Catheter with Guidewire Tip

Map-iT

FDA UDI

ACCESS POINT TECHNOLOGIES, INC.·00818087020237·Steerable Duo-Decapolar Catheter, Multi-Purpose...

Map-iT

FDA UDI

ACCESS POINT TECHNOLOGIES, INC.·00818087020176·Fixed Curve Duo-Decapolar Catheter with Guidewi...

Map-iT

FDA UDI

ACCESS POINT TECHNOLOGIES, INC.·00818087020275·Steerable Duo-Decapolar Catheter, Multi-Purpose...

Map-iT

FDA UDI

ACCESS POINT TECHNOLOGIES, INC.·00818087020220·Steerable Duo-Decapolar Catheter, Multi-Purpose...

Map-iT

FDA UDI

ACCESS POINT TECHNOLOGIES, INC.·00818087020084·Steerable Decapolar Catheter, Multi-Purpose D C...