Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·BELOS & LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S

Coccidioides Antigen

FDA registration

IMMY, Inc.·1 product·🇺🇸 United States

CANDIDA IMMUNODIFFUSION (ID) KIT

FDA registration

IMMY, Inc.·1 product·🇺🇸 United States

100405 Coccidioides F antigen

FDA registration

MERIDIAN BIOSCIENCE, INC.·1 product·🇺🇸 United States

QDXC90 - Coccidioides CF Antigen

FDA registration

IMMY, Inc.·1 product·🇺🇸 United States

M6-C

FDA UDI

Spinal Kinetics, Inc.·00812388030445·Acute Disc Removal Tool, M/ML, G6

M6-C

FDA UDI

Spinal Kinetics, Inc.·00812388030452·Acute Disc Removal Tool, L/LL, G6

NA

FDA UDI

Synthes GmbH·00845384011750·Electric Systems Foot Control With Direction Only

Custom Burn Garments

FDA registration

MEDICAL Z, S.A.·1 product·🇫🇷 France

MOUTH SPACER

FDA registration

MEDICAL Z, S.A.·1 product·🇫🇷 France

Mammostat

FDA registration

MEDICAL Z, S.A.·1 product·🇫🇷 France

MEDIGEL Z

FDA registration

MEDICAL Z, S.A.·1 product·🇫🇷 France

MATERNITY SUPPORT DEVICE

FDA registration

MEDICAL Z, S.A.·1 product·🇫🇷 France

ZBra (S/014, S/020, S/021, S/024, S/036, EZ/005)

FDA registration

MEDICAL Z, S.A.·1 product·🇫🇷 France

RIGEL 3DR Anterior Cervical Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

IDAS INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

AERONEB SOLO; AERONEB SOLO ADAPTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

CAPTIAM SYPHILIS-G ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

e-Celsius Medical System

FDA 510(k)

FDA Class 2 ·General Hospital