Infinity Acute Care System (IACS) Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Infinity Acute Care System (IACS) Monitoring Solution

FDA 510(k)

FDA Class 2 ·Cardiovascular

INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION

FDA 510(k)

FDA Class 2 ·Cardiovascular

KINAMED REALITY TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIP

FDA 510(k)

FDA Class 2 ·Orthopedic

Vertex Hip Fracture Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

Solo+ Tympanostomy Tube Device (TTD)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AUTONEB ACCESSORY CROSS (AAC)

FDA 510(k)

FDA Class 2 ·Anesthesiology

SENSUA!

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AWARE PAD

FDA 510(k)

FDA Class 2 ·Radiology

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ADG BONE PLUG

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sublime Radial Access 018 RX Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MIAMI-SUNNY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HD Lumbar Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

OSW Aligner System

FDA 510(k)

FDA Class 2 ·Dental