P2psa

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech PSA Reagents on the Access Immunoassay Systems

Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1

FDA 510(k)

FDA Class 2 ·Cardiovascular

SILGEL STC-S

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CRE Pulmonary Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Hygenix

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Patient Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO

FDA 510(k)

FDA Class 2 ·Radiology

All-in-One Health Monitor, PC-303

FDA 510(k)

FDA Class 2 ·Cardiovascular

NitriTec Vinyl Glove Powder Free Blue

FDA 510(k)

FDA Class 1 ·General Hospital

Contour+ (MVision AI Segmentation)

FDA 510(k)

FDA Class 2 ·Radiology

MVision AI Segmentation

FDA 510(k)

FDA Class 2 ·Radiology

CRE RX Biliary Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators

FDA 510(k)

FDA Class 2 ·General Hospital

Safe Secure Sterilization Pouches and Rolls

FDA 510(k)

FDA Class 2 ·General Hospital

IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS

FDA 510(k)

FDA Class 2 ·Radiology