66 results · 20ms · 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.

Medical Mask

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

NuVasive

FDA UDI
Nuvasive, Inc.·00195377106087·NTS Dilator, 20mm

Phasix

FDA UDI
Davol Inc.·00801741161230·Phasix ST Mesh with Echo 2 Positioning System, ...

ViSi

FDA UDI
Sotera Wireless, Inc.·00850733007025·The ViSi thumb sensor is an accessory intended ...

InSePtion MIS Fixation System

FDA UDI
Kalitec Direct LLC·B07314K0100200·Caddie, Implant

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK0100200·SNII Screwdriver, Poly Std Assembly

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0100200·Caddie Lid, All Sizes

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0100200·Caddie, Rods, 5.5mm Assembly

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

SCHWARTZ ELECTRO-OPTICES, INC. TRILASE 2100/20 HOLMIUM LASER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

TERASON T3200 ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

VIVIX-S

FDA 510(k)
FDA Class 2 ·Radiology

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon Catheter

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon catheter

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval
FDA Class 3 ·Optilume Urethral Drug Coated Balloon