Igm, Rhodamine, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Igm, Rhodamine, Antigen, Antiserum, Control

UTERMOHLEN CRYO PROFESSIONAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml

FDA 510(k)

FDA Class 2 ·Microbiology

Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIFESCOPE 8 DEC-8108A AND DEC-8204A

FDA 510(k)

FDA Class 2 ·Cardiovascular

MS-39

FDA 510(k)

FDA Class 2 ·Ophthalmic

Wishbone HA

FDA 510(k)

FDA Class 2 ·Dental

LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANA ANTISERA CONTROL KIT

FDA 510(k)

FDA Class 2 ·Immunology

MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST

FDA 510(k)

FDA Class 2 ·Immunology

RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

AC3 Series Intra-Aortic Balloon Pump (IABP)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCESS R-CLONE ANA PROFILE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

RHEUMELISA ASSAY FOR SM AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV