Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGIFOAM ABSORBABLE GELATIN SPONGE

PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·GRUNTZIG DILACA BALLOON DILATATION CATHETERS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·DRIVER AND MICRODRIVER CORONARY STENT SYSTEMS

SmartTarget

FDA 510(k)

FDA Class 2 ·Radiology

ProSomnus® EVO Sleep and Snore Device

FDA registration

PROSOMNUS SLEEP TECHNOLOGIES·3 products·🇺🇸 United States

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORONARY FLEXTOME CUTTING BALLOON DEVICE

Rocket Platinum Cured Cathter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GUIDEWIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRODOSE AAD SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

CAPTIAM SYPHILIS-G ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

LOGIFLEX LAPAROSCOPIC BAND POSITIONING DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UNI-GOLD STREP A TEST KIT

FDA 510(k)

FDA Class 1 ·Microbiology

ENDOMETRIAL SAMPLING SYRINGE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SONICAID MODEL P110 FETAL HEAR DETECTOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Rocket Indwelling Pleural Catheter (IPC) Insertion Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology