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FDA 510(k)

FDA Class 2 ·Cardiovascular

SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,

FDA 510(k)

FDA Class 2 ·Anesthesiology

AMG MED BRAND CLINICAL GLASS THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

Models 2200DR and 1600DR Digital Stationary Radiographic Systems

FDA 510(k)

FDA Class 2 ·Radiology

PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·OSTEOSPACE

Tek RMD (Tek Robotic Mobilization Device)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SpydrBlade Flex Instrument (PRD-RG1-001)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ABI Instrument, Creo Electrosurgical System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Reusable Interface Cable 1.5 m (PRD-IFC-002)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Speedboat Flush SB1 Instrument

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Creo Electrosurgical System with HS1 Hemostasis Accessory

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AB1 Electrosurgical Instrument, Creo Electrosurgical System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NP1 Instrument, Creo Electrosurgical System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501

FDA 510(k)

FDA Class 2 ·Immunology

Creo Electrosurgical System with NP1 Instrument

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery