Aspirex Thrombectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DOC BAND-POSTOP

FDA 510(k)

FDA Class 2 ·Neurology

UltraCor Twirl Breast Tissue Marker

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ARTERIAL EMBOLECTOMY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50-

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)

FDA 510(k)

FDA Class 2 ·Cardiovascular

GammaTile

FDA 510(k)

FDA Class 2 ·Radiology

IMPRA CARBOFLO EPTFE VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5

FDA 510(k)

FDA Class 2 ·Cardiovascular

CONQUEST PTA BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; JUGULAR/SUBCLAVAIN DELIVERY KIT, MODEL RF-320J

FDA 510(k)

FDA Class 2 ·Cardiovascular