CHISEL, BONE, SURGICAL

FDA 510(k)

FDA Class 1 ·Orthopedic

P AND T MEDIUM

FDA 510(k)

FDA Class 1 ·Microbiology

GSO PCT SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Isopure Dry Acid Dissolution System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CustMBite Dental Guard

FDA 510(k)

FDA Unclassified ·Unknown

NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P

FDA 510(k)

FDA Class 2 ·General Hospital

INTDose

FDA 510(k)

FDA Class 2 ·Radiology

NIPRO HYPODERMIC NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX

FDA 510(k)

FDA Class 2 ·General Hospital

COPRA TEMP PMMA-DISK

FDA 510(k)

FDA Class 2 ·Dental

CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

4-Part Telescoping Herbst Replacement Parts

FDA UDI

SPECIALTY APPLIANCES, LLC·D8199002520·

3-Part TS Herbst Kit

FDA UDI

SPECIALTY APPLIANCES, LLC·D8199002510·

Traditional Herbst Replacement Parts

FDA UDI

SPECIALTY APPLIANCES, LLC·D8199002530·

Antistreptolysin “O”

Basic UDI-DI

EU IVDR · Eu Ivd Class B ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·10 devices

KJ-106 GB101 GB111 DM330 DM331 DM350

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Wenzhou Kangju Medical Instrument Co., Ltd·6 devices

FI13/07001

Certificate

MDD Annex II (excluding section 4)·Optomed Oyj·SGS FIMKO OY·6 Basic UDI-DIs

FI24/00000061

Certificate

MDR QMS·Optomed Oyj·SGS FIMKO OY

FI120/07001P0

Certificate

MDD Annex II (excluding section 4)·Optomed Oyj·SGS FIMKO OY·1 Basic UDI-DI