SURGICAL OSCILLATING SAW

FDA 510(k)

FDA Class 2 ·Dental

ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS

FDA 510(k)

FDA Class 2 ·Dental

DENTATUS OSCIOMAT

FDA 510(k)

FDA Class 2 ·Dental

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

Elecsys Anti-SARS-CoV-2

FDA 510(k)

FDA Class 2 ·Microbiology

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator

FDA 510(k)

FDA Class 2 ·Microbiology

ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TAIDOC CHECK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·VIS-SOL STERILE PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ISOTONIC STERILE UNPRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·VIS-SOL STERILE PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ISOTONIC STERILE UNPRESERVED SALINE SOLUTION

EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AGILIS NXT STEERABLE INTRODUCER, MODEL G408324

FDA 510(k)

FDA Class 2 ·Cardiovascular

Impulse Angiographic Catheter, Expo Angiographic Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2

FDA 510(k)

FDA Class 2 ·Cardiovascular

Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323

FDA 510(k)

FDA Class 2 ·Cardiovascular

Xpert® Xpress CoV-2 plus

FDA 510(k)

FDA Class 2 ·Microbiology