Obturators, Cannula Sheaths

FDA registration

KARL STORZ SE & CO KG·1 product·🇩🇪 Germany

CALCUSPLIT

FDA registration

KARL STORZ SE & CO KG·1 product·🇩🇪 Germany

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE CARDIOVETER DEFIBRILLATOR, DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA MINI, EL, ICD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRISM/PRIZM 2/ CONTAK CD2/VITALITY DS/EL MODEL 2844 VERSION 3.8

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRIZM, PRIZM HE, PRIZM 2, VITALITY, VITALITY AVT, VITALITY DS, VITALITY EL

Endoscope Valves Set

Basic UDI-DI

EU MDR · Eu Md Class 1 ·G-FLEX FLEXIBLE INSTRUMENTS EUROPE·4 devices

Pitkar DeftFix System

FDA 510(k)

FDA Class 2 ·Orthopedic

Pitkar External Fixation System - Rail Mechanism

FDA 510(k)

FDA Class 2 ·Orthopedic

Pitkar External Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Pitkar Spinal Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Phoenix Digital Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

Pitkar Locked Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

IMAGE1 SPIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NIDEK, INC. MODEL ADC-8000 DERM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TIPCAM1 Rubina Video Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TARGET COCAINE METABOLITE-V

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ENDOFLATOR 40, ENDOFLATOR 50

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

POLYCORD II

FDA 510(k)

FDA Class 2 ·Cardiovascular

HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Radlink GPS

FDA 510(k)

FDA Class 2 ·Radiology