Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL PMS 1000 PROGRAMMING AND MONITORING SYSTEM WITH SOFTWARE MODULE SWM 1000, VERSION C01.C02.U

ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable

FDA 510(k)

FDA Class 2 ·General Hospital

ivWatch® Model 400

FDA 510(k)

FDA Class 2 ·General Hospital

ivWatch

FDA 510(k)

FDA Class 2 ·General Hospital

ivWatch Model 400

FDA 510(k)

FDA Class 2 ·General Hospital

ivWatch Model 400

FDA 510(k)

FDA Class 2 ·General Hospital

TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)

FDA 510(k)

FDA Class 2 ·Neurology

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LEXOS DR/VR(-T) ICDS & LUMOS VR/DR (-T) & XELOS DR-T ICD & BELOS DR (-T) ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CARDIAC AIRBAG (-T) ICDS & BELOS VR (-T) ICDS & TMS 1000 PLUS PROGRAMMING SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·KRONOS LV-T CRT-D & LUMAX VR/DR/HF (-T) ICDS & CDT-DS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CYLOS PACEMAKER & PHILOS II PACEMAKERS & ICS 3000 IMPLANT CONTROL SYSTEM & IMPLANT MODULE

Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)

FDA 510(k)

FDA Class 2 ·Neurology

Source Abroad

FDA UDI

Broder Bros., Co.·00030028000027·PL-2335 Digital Thermometer Source Abroad over...

Source Abroad

FDA UDI

Broder Bros., Co.·00030028000065·PL-2335 Digital Thermometer Source Abroad overs...

Source Abroad

FDA UDI

Broder Bros., Co.·00030028000089·PL-2335 Digital Thermometer Source Abroad over...

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

Agent, Injectable, Embolic

FDA Pre-Market Approval

FDA Class 3 ·Apollo Onyx Delivery Micro Catheter

TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)

FDA 510(k)

FDA Class 2 ·Neurology

Cook

FDA UDI

COOK INCORPORATED·00827002019140·Central Venous Catheter Set

Cook

FDA UDI

COOK INCORPORATED·00827002028388·Pressure Monitoring Set