Scientek

FDA registration

SCIENTEK TECHNOLOGY CORPORATION·1 product·🇨🇦 Canada

Spire Health Remote Patient Monitoring System

FDA UDI

Spire, Inc.·00860008932204·The Spire Health Remote Patient Monitoring Syst...

Spire Health Remote Patient Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICRO-SURGICAL POWER INSTRUMENT SYS.

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DERMABRADERS

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

MICRO-SUGICAL POWER INSTRUMENT SYSTEM

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

MICRO-SURGICAL POWER INSTRUMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MICRO DRILLS

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

RETRO REPAIR KIT, MODEL PRRK5

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology