Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER THERMOCOUPLE OR THERMISTOR

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS and EZ STEER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVISTAR ELECTROPHYSIOLOGY CATHETER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Navistar RMT Electrophysiology Catheter

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVISTAR Electrophysiology Catheter, EZ Steer NAV Bi-Directional Electrophysiology Catheter, NAVISTAR RMT Electrophysiol

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·STOCKERT 70 RF GENERATOR WITH SOFTWARE VERSION 1.033

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·KENTROX RV 65, KENTROX RV 75, KAINOX SL 65/13, KAINOX SL 65/18

Acuitas AMR Gene Panel

FDA 510(k)

FDA Class 2 ·Microbiology

cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert Carba-R

FDA 510(k)

FDA Class 2 ·Microbiology

cobas BKV

FDA 510(k)

FDA Class 2 ·Microbiology

GenePOC Carba

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)

FDA 510(k)

FDA Class 2 ·Microbiology

ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)

FDA 510(k)

FDA Class 2 ·Microbiology

HSV 1 & 2 ELITe MGB Kit; ELITe InGenius

FDA 510(k)

FDA Class 2 ·Microbiology

QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Solana HSV 1+2/VZV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m HSV 1 & 2 / VZV

FDA 510(k)

FDA Class 2 ·Microbiology