Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Series Product Line/ Implantable Penile Prosthesis (IPP) with and without Inhibizone Treatment

HD Analyzer

FDA UDI

VISIOMETRICS SL·18437014903024·HD Analyzer Optical Quality Analysis System

TearFilm Analyzer

FDA UDI

VISIOMETRICS SL·18437014903031·TearFilm Analyzer Optical Quality Analysis System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC EN-TRUST 30J/35J ICD FAMILY

MEDİSAM TIBBİ ÜRÜNLER VE CİH. TEKS. İTH. İHR. SAN. TİC. LTD. ŞTİ.

Manufacturer

🇹🇷 Türkiye

ZERKAYA TEKSTİL MEDİKAL GIDA İNŞAAT İTH. İHR. SAN. VE TİC. LTD. ŞTİ.

Manufacturer

🇹🇷 Türkiye·5 Basic UDI-DIs·5 Devices

ReJoyce

FDA UDI

Rehabtronics Inc·17540176010002·The ReJoyce is a rehabilitation device intended...

SaeboRejoyce

FDA UDI

SAEBO, INC.·00850331006567·Virtual-display arm rehabilitation system

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COSMOS II(R) PULSE GENERATORS MODEL 283-03, 284-05

VRPhysio

FDA UDI

XR HEALTH IL LTD·07290016986099·A software-only medical device intended for cer...

VRPhysio

FDA UDI

XR HEALTH IL LTD·07290016986082·A software-only medical device intended for upp...

VRCogni

FDA UDI

XR HEALTH IL LTD·07290016986112·A software-only medical device intended to aid ...

VRCBT

FDA UDI

XR HEALTH IL LTD·07290016986143·The AT-910 ("A10tion") is a is a virtual realit...

VRPhysio

FDA UDI

XR HEALTH IL LTD·07290016986037·A software-only medical device intended for cer...

VRPhysio

FDA UDI

XR HEALTH IL LTD·07290016986044·A software-only medical device intended for upp...

VRPhysio

FDA UDI

XR HEALTH IL LTD·07290016986013·A software-only medical device intended for upp...

VRReliever

FDA UDI

XR HEALTH IL LTD·07290016986129·The MD-710 ("Relax8") is intended to assist in ...

VRPhysio

FDA UDI

XR HEALTH IL LTD·07290016986020·A software-only medical device intended for cer...

VRReliever

FDA UDI

XR HEALTH IL LTD·07290016986136·The PD-810 ("Mindset") is intended to assist in...

VRCogni

FDA UDI

XR HEALTH IL LTD·07290016986105·A software-only medical device intended to aid ...