COORDINATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRIMEDIC DEFIBRILLATORS-N/B

FDA 510(k)

FDA Class 2 ·Cardiovascular

DATASCOPE INTERNAL DEFIBRILLATOR PADDLES

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

K-STIK DEFIBRILLATION PADS

FDA 510(k)

FDA Class 2 ·Cardiovascular

BATTERY PACK

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rapid Hair Removal Pads

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARDIOPAC DEFIBRILLATOR 444

FDA 510(k)

FDA Class 2 ·Cardiovascular

Kit, Typing, Hla-Dqb

FDA classification

FDA Class 2 ·Kit, Typing, Hla-Dqb

PCI 2500

FDA 510(k)

FDA Class 2 ·Physical Medicine

Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Haptoglobin, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Haptoglobin, Fitc, Antigen, Antiserum, Control

Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

FDA classification

FDA Class 2 ·Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE

FDA 510(k)

FDA Class 2 ·Anesthesiology

SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery