System, Oxygen, Aqueous

FDA Pre-Market Approval

FDA Class 3 ·TherOx Downstream System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·OBALON BALLOON SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon Kit

α-AMY Rapid Test Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Anbio (Xiamen) Biotechnology Co.,Ltd.·1 device

NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 AMY RGT KIT Product No. ST227

FDA UDI

CAROLINA LIQUID CHEMISTRIES CORPORATION·00817302020274·AMY (Amylase) 4 x 250 tests

COSGROVE DEPTH ELECTRODE KIT(CDEK)

FDA 510(k)

FDA Class 2 ·Neurology

OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]

FDA 510(k)

FDA Class 2 ·Neurology

ELI 250 ELECTROCARDIOGRAPH

FDA 510(k)

FDA Class 2 ·Cardiovascular

OPTICAL TRACKING SYSTEM (OTS)

FDA 510(k)

FDA Class 2 ·Neurology

PACE-1A CARDIAC STIMULATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

LASER MECHANISMS LASER SCANNING SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Jig, Piston Cutting, Ent, Non-Sterile

FDA classification

FDA Class 1 ·Jig, Piston Cutting, Ent, Non-Sterile

CMI s.r.o.

Importer

🇨🇿 Czechia·3 Manufacturers

FLOW-EZE BLUNT CANNULA (1999BC)

FDA 510(k)

FDA Class 2 ·General Hospital

DILUTION SPIKE

FDA 510(k)

FDA Class 2 ·General Hospital

Insulin Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

NIO-I

FDA 510(k)

FDA Class 2 ·General Hospital

Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set

FDA 510(k)

FDA Class 2 ·General Hospital