Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

MONITOR ONE NDX

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

PATHWAY ACCESS SHEATH CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PATHWAY ACCESS SHEATH CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KOBRA GPS FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLEARFLASH AC2100 COSMETIC SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )

FDA 510(k)

FDA Class 2 ·Microbiology

Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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