Welch Allyn, Inc.

FDA UDI

WELCH ALLYN, INC.·00732094294118·H12+ 12-lead digital Holter Recorder - 48-hour ...

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COMBI 40+COCHLEAR IMPLANT SYSTEM,C40+S(COMPRESSED)ELECTRODE ARRAY/C40+ GB (SPLIT) ELECTRODE ARRAY

FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URETEROSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OES Elite Ureteroscopes and Accessories

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RIGID URETEROSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Avicenna Roboflex

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Monarch Platform, Urology

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Medical Video Endoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Flexible Video-Uretero-Renoscope SSU System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OLYMPUS URF-P6/P6R

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOSCOPE AND ACCOSSORIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology