STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device

FDA 510(k)

FDA Class 2 ·Orthopedic

IDEAL LIFE BP-MANAGER, MODEL BPM 0001; IDEAL LIFE POD, MODEL ILP 0001

FDA 510(k)

FDA Class 2 ·Cardiovascular

JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO

FDA 510(k)

FDA Class 2 ·Anesthesiology

Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System

FDA 510(k)

FDA Class 2 ·Orthopedic

SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene; SeaSpine Vu e•POD System; and SeaSpine Reef TH System, SeaSpine Vu a•POD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System

FDA 510(k)

FDA Class 2 ·Orthopedic

JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON

FDA 510(k)

FDA Class 2 ·Cardiovascular

Temporary, Internal Use Hemostatic

FDA classification

FDA Class 2 ·Temporary, Internal Use Hemostatic

HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

HEMOTEC ACT I SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

EMERGENT TECHNOLOGY VENTILATORY EFFORT MONITOR VEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR

FDA 510(k)

FDA Class 2 ·Hematology

TORQUE FITTING

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDICAL BATTERY PACKS

FDA 510(k)

FDA Class 2 ·General Hospital