Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX STREAK & ACS FLOW TRACK 40

Pump, Infusion, Pca

FDA classification

FDA Class 2 ·Pump, Infusion, Pca

WECK TROCAR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PNEUMO-SEAL(TM)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LM15(TM), CATALOG NUMBER - 523821

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WECK LX TM SKIN STAPLER

FDA 510(k)

FDA Class 2 ·General Hospital

SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HEMOCLIP II

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

WECK ELECTROSURGICAL GENERATOR #174200

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CORONARY ARTERY BYPASS GRAFT (CABG) MARKER

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEM-O-LOK(TM)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BOWIE-DICK TEST CARD CATALOG NUMBER 008018

FDA 510(k)

FDA Class 2 ·General Hospital

SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER

FDA 510(k)

FDA Class 2 ·Microbiology

ACTOnco, ACTOnco IVD

FDA 510(k)

FDA Class 2 ·Pathology

“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”

FDA 510(k)

FDA Class 2 ·Pathology

Philips IntelliSite Pathology Solution 5.1

FDA 510(k)

FDA Class 2 ·Pathology

NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)

FDA 510(k)

FDA Class 2 ·Pathology